Wearable Medical Device Controller With Capacitor Framing

ABSTRACT

A serviceable wearable cardiac treatment device for continuous extended use by an ambulatory patient includes a garment, a device controller, and an ingress-protective housing. The garment is configured to dispose therein a plurality of ECG sensing and therapy electrodes to monitor for and treat a cardiac arrhythmia in the patient. The device controller is configured to be in separable electrical communication with the plurality of ECG sensing and therapy electrodes and includes an impact-resistant energy core, and first and second circuit boards affixed to opposing sides of the impact-resistant energy core. The impact-resistant energy core includes a frame and at least one capacitor permanently bonded to the frame to form a unitary mass. The ingress-protective housing is configured to enable removal of the impact-resistant energy core and the first and second circuit boards during servicing.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/949,467, titled “WEARABLE MEDICAL DEVICE CONTROLLER WITH CAPACITORFRAMING” filed Oct. 30, 2020, which claims the benefit of U.S.Provisional Application Ser. No. 62/929,721, titled “WEARABLE MEDICALDEVICE CONTROLLER WITH CAPACITOR FRAMING” filed on Nov. 1, 2019. Allsubject matter set forth in the above referenced application is herebyincorporated by reference in its entirety into the present applicationas if fully set forth herein.

BACKGROUND

The present disclosure is directed to wearable cardiac monitoring andtreatment devices.

A patient suffering from heart failure experiences symptoms caused by aweak or damaged heart contracting inefficiently and failing to pumpeffectively to circulate oxygenated blood through the body. A heart maybe weakened by, for example, abnormal heart rhythms (e.g., heartarrhythmias), high blood pressure, coronary artery disease, myocardialinfarction, and myocarditis.

Left untreated, heart failure could lead certain life-threateningarrhythmias. Both atrial and ventricular arrhythmias are common inpatients with heart failure. One of the deadliest cardiac arrhythmias isventricular fibrillation, which occurs when normal, regular electricalimpulses are replaced by irregular and rapid impulses, causing the heartmuscle to stop normal contractions. Because the victim has noperceptible warning of the impending fibrillation, death often occursbefore the necessary medical assistance can arrive. Other cardiacarrhythmias can include excessively slow heart rates known asbradycardia or excessively fast heart rates known as tachycardia.

Cardiac arrest can occur when various arrhythmias of the heart, such asventricular fibrillation, ventricular tachycardia, pulseless electricalactivity (PEA), and asystole (heart stops all electrical activity),result in the heart providing insufficient levels of blood flow to thebrain and other vital organs for supporting life. It is generally usefulto monitor heart failure patients in order to assess heart failuresymptoms early and provide interventional therapies as soon as possible.

Wearable cardiac monitoring and treatment devices are provided tomonitor for such arrhythmias and provide a treatment when alife-threatening arrhythmia is detected. Such devices are worn by thepatient continuously to provide constant protection. These devices areoften refurbished and reused by subsequent patients. As such, thedevices need to be designed to be resilient and easy to service.

SUMMARY

In one example, a serviceable wearable cardiac treatment device forcontinuous extended use by an ambulatory patient includes a garment anda device controller. The garment is configured to dispose therein aplurality of ECG sensing and therapy electrodes in continuous extendedcontact with the patient to monitor for and treat a cardiac arrhythmiain the patient. The device controller is configured to be in separableelectrical communication with the plurality of ECG sensing and therapyelectrodes in the garment. The device controller includes animpact-resistant energy core and an ingress-protective housing. Theimpact-resistant energy core includes a frame, at least one capacitorand first and second circuit boards affixed to opposing sides of theenergy core. The at least one capacitor is permanently bonded to theframe such that the frame along with the bonded at least one capacitoris a unitary mass. The at least one capacitor configured to holdelectrical charge sufficient to treat the cardiac arrhythmia. The firstand second circuit boards include cardiac arrhythmia monitoring andtherapy circuitry in electrical communication with the at least onecapacitor. The first and second circuit boards are affixed to opposingsides of the impact-resistant energy core in a manner to allow forseparation from the impact-resistant energy core during service. Theingress-protective housing is configured to enable removal of theimpact-resistant energy core and the first and second circuit boardsduring service.

Implementations of the device may include one or more of the followingfeatures.

In examples, the frame includes a pocket configured to receive the atleast one capacitor therein. The device can include a compound disposedwithin the pocket to at least partially encapsulate the at least onecapacitor thereby immovably binding the at least one capacitor to theframe to form the unitary mass. In examples, the compound includes aninsulating material encasing the at least one capacitor within thepocket. The compound can include an epoxy resin that when set afterinitial application has a hardness rating in a range of about 80-85Shore D. In implementations, the compound is an adhesive compound.

In examples, the at least one capacitor includes a film capacitor. Inexamples, the at least one capacitor includes at least two capacitors.

In examples, the device includes at least one wire extending from theimpact-resistant energy core. In examples, the at least one capacitorincludes two capacitors connected in parallel and the at least one wireis connected to the first circuit board. In examples, the two capacitorsare two film capacitors arranged side-by-side each comprising two majorplanes such that the two major planes of each of the two film capacitorsare disposed adjacent a first side and a second side of the frame.

In examples, the at least one capacitor is configured to occupy at least50 to 95 percent of a volume defined within a pocket in the frame.

In examples, the device includes a gap between the at least onecapacitor and an inner surface of the frame, the gap being between 0.5to 10 mm.

In examples, the device includes one or more releasable fastenersconfigured to affix the first and second circuit boards to opposingsides of the impact-resistant energy core. The one or more releasablefasteners can include one or more of screws, clamps, snaps, clips, andtape.

In examples, the first circuit board includes at least one processor andhigh voltage circuitry in communication with the at least one processor.The at least one processor can include an arrhythmia detectionprocessor. The at least one processor includes an arrhythmia detectionprocessor and a therapy control processor. The high voltage circuitrycan include a therapy delivery circuit.

In examples, the device includes a flex connector extending from thefirst circuit board to the second circuit board. The second circuitboard can include low voltage circuitry, and the low voltage circuitryincludes communication circuitry. In examples, the first circuit boardincludes a display mount configured to retain a display screen in wiredcommunication with the second circuit board.

In examples, the impact-resistant energy core and the affixed first andsecond circuit boards occupy between about 25%-90% of a volume definedby the ingress-protective housing.

In examples, the ingress-protective housing includes a rear shellconfigured to be disposed adjacent the second circuit board and a frontshell configured to be disposed adjacent the first circuit board, thefront shell mating with the rear shell in a sealed configuration. Inimplementations, the ingress-protective housing has an IP67 or IP66rating as set forth in the IEC 60529 Standard for Ingress Protection. Inimplementations, the ingress-protective housing has a rating of at leastone of IP6X, IPX6, and IPX7, wherein the “X” is a variable representinga rating on a scale of 1 through 9 as set forth in the IEC 60529Standard for Ingress Protection. A mating edge of the front shell and amating edge of the rear shell are configured to engage in a fittedinterlock when the front and rear shells are mated to form theingress-protective housing. In implementations, at least one of thefront and rear shells includes a mortise in the mating edge and theother of the front and rear sells includes a projection configured toengage the mortise. The fitted interlock can include a compressiblesilicone seal configured to be disposed in the mortise.

In examples, the front and rear shells are configured to be held in thesealed configuration by one or more releasable fasteners. The device caninclude one or more plates configured to be secured over the one or morereleasable fasteners to prevent ingress of liquid and particulatematter.

In examples, the front shell and the rear shell are configured to beseparated for removal and replacement of at least the impact-resistantenergy core and the affixed first and second circuit boards. Inimplementations, the front shell can include a touch screen disposedtherein, and the touch screen can be affixed to the front shell via aningress-protective sealant. In implementations, the front shell includesa speaker disposed therein, and the speaker is sealed with aningress-protective sealant.

In examples of the device, the separable electrical communicationincludes a connector in communication with the plurality of ECG sensingand therapy electrodes. The connector configured to be mated to theingress-protective housing in electrical communication with one or bothof the first and second circuit boards. In examples, theingress-protective housing includes a receiving port for the connector,and the receiving port being in electrical communication with one orboth of the first and second circuit boards. In implementations, thereceiving port includes a grommet configured to receive mating edges ofthe front and rear shells in the sealed configuration of theingress-protective housing. The grommet includes an upper flange and alower flange and a well therebetween to receive the mating edges of thefront and rear shells therein.

In examples, the rear shell further includes a battery connectorextending therethrough configured to receive a complimentary connectorof a removable battery. In implementations, the battery connector issealed with an ingress-protective sealant and is configured to be inwired communication with at least one processor disposed on the firstcircuit board. The ingress-protective sealant is at least one of epoxyand pressure sensitive adhesive. The device can further include a flexconnector extending between the battery connector and the first circuitboard within the ingress-protective housing.

In examples, the rear shell defines a compartment configured to receivea removable battery module such that outer surfaces of the removablebattery module are flush with outer surfaces of the ingress-protectivehousing in a mated configuration.

In examples, the rear shell further includes at least at least one shockabsorbing spacer configured to protect the impact-resistant energy coreand the affixed first and second circuit boards from mechanical impact.In implementations, the front shell further includes at least at leastone shock absorbing spacer configured to protect the impact-resistantenergy core, and the affixed first and second circuit boards frommechanical impact.

In examples, the device further includes at least one shock absorbingspacer disposed within the ingress-protective housing. The at least oneshock absorbing spacer configured to support the impact-resistant energycore and the affixed first and second circuit boards within theingress-protective housing.

In examples, the plurality of ECG sensing electrodes are configured tosense an ECG signal of the patient for further analysis by at least oneprocessor disposed on the first circuit board.

In implementations, a method of constructing a serviceable wearablecardiac treatment device controller for continuous extended use by anambulatory patient includes providing a frame and inserting at least onecapacitor into the frame. The at least one capacitor can be configuredto hold electrical charge sufficient to treat a cardiac arrhythmia of apatient. The method includes bonding the at least one capacitor to theframe such that the frame along with the bonded at least one capacitorcomprises an impact-resistant energy core. The method includes affixingfirst and second circuit boards to opposing sides of theimpact-resistant energy core in a manner to allow for separation fromthe impact-resistant energy core during service, the first and secondcircuit boards comprising cardiac arrhythmia monitoring and therapycircuitry in electrical communication with the at least one capacitor,and enclosing the energy core and the affixed first and second circuitboards within an ingress-protective housing configured to enable removalof the impact-resistant energy core and the first and second circuitboards during service.

Implementations of the method may include one or more of the followingfeatures.

In implementations, the frame includes a pocket for receiving thereinthe at least one capacitor therein. Bonding the at least one capacitorto the frame includes disposing a self-curing polymer within the pocketto at least partially encapsulate the at least one capacitor and therebyimmovably bind the at least one capacitor to the frame to form a unitarymass.

The ingress-protective housing can include a rear shell configured to bedisposed adjacent the second circuit board and a front shell configuredto be disposed adjacent the first circuit board. In implementations ofthe method of constructing the serviceable wearable cardiac treatmentdevice controller includes enclosing the energy core and the affixedfirst and second circuit boards within an ingress-protective housing bymating a front shell with the rear shell in a sealed configuration. Themethod can include securing the front and rear shells in their sealedconfiguration with one or more releasable fasteners.

Mating the front and rear shell can include engaging a mating edge ofthe front shell and a mating edge of the rear shell in a fittedinterlock to form the ingress-protective housing. In implementations,mating the front and rear shells includes engaging a mortise disposed ona mating edge of one of the front and rear shells with a projectiondisposed on a mating edge of the other of the one of the front and rearshells. The method can further include disposing a compressible siliconeseal in the mortise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a schematic front view of an example wearable cardiacmonitoring and treatment device including a device controller.

FIG. 2 depicts a schematic diagram of an embodiment of a devicecontroller for a wearable cardiac monitoring and treatment device.

FIG. 3 depicts a front perspective view of a core assembly of an exampledevice controller for a wearable cardiac monitoring and treatmentdevice.

FIG. 4 depicts an exploded view of the core assembly of FIG. 3 .

FIG. 5 depicts an exploded view of an example device controller for awearable cardiac monitoring and treatment device.

FIG. 6A depicts an exploded perspective view of an example framingassembly for a capacitor for an example device controller for a wearablecardiac monitoring and treatment device.

FIG. 6B depicts a plan view of the example framing assembly of FIG. 6A.

FIG. 6C depicts a perspective view of another example framing assemblyfor a capacitor for an example device controller for a wearable cardiacmonitoring and treatment device.

FIG. 6D depict a plan view of the example framing assembly of FIG. 6C.

FIG. 7 depicts a side cross section of an example assembled devicecontroller for a wearable cardiac monitoring and treatment device.

FIG. 8 depicts a front perspective view of an internal assembly of anexample device controller for a wearable cardiac monitoring andtreatment device.

FIG. 9 depicts a rear perspective view of the internal assembly of FIG.8 .

FIG. 10A depicts an exploded view of an example enclosure for a devicecontroller for a wearable cardiac monitoring and treatment device.

FIG. 10B depicts a magnified view of a gasket portion of the enclosureof FIG. 10A.

FIG. 11A depicts a perspective side view of an example assembled devicecontroller for a wearable cardiac monitoring and treatment device.

FIG. 11B depicts top view of an example assembled device controller fora wearable cardiac monitoring and treatment device.

FIG. 12 depicts a schematic cross section of a mating portion of anexample assembled device controller for a wearable cardiac monitoringand treatment device.

FIG. 13 depicts a portion of a side view of an example assembled devicecontroller for a wearable cardiac monitoring and treatment device.

FIG. 14A depicts a rear perspective view of an example assembled devicecontroller for a wearable cardiac monitoring and treatment device withthe battery removed.

FIG. 14B depicts a rear perspective view of the example assembled devicecontroller of FIG. 14A with the battery inserted.

FIG. 15 depicts an example battery connector for a device controller fora wearable cardiac monitoring and treatment device.

FIG. 16 depicts a plan view of an internal surface of an example housingfor a device controller for a wearable cardiac monitoring and treatmentdevice.

FIG. 17 is a schematic of an example method of using a wearable cardiacmonitoring and treatment device.

FIG. 18 depicts a schematic diagram of an embodiment of electricalcomponents of a controller for a cardiac monitoring and treatmentdevice.

FIG. 19A depicts a view of an example capacitor assembly for devicecontroller for a wearable cardiac monitoring and treatment device.

FIG. 19B depicts a rotated view of the example capacitor assembly ofFIG. 19A

FIG. 20 depicts an example method of constructing a serviceable wearablecardiac treatment device controller for continuous extended use by anambulatory patient.

DETAILED DESCRIPTION

Heart failure patients can be prescribed a cardiac monitoring device ora cardiac monitoring and treatment device. In some cases, physicians mayuse medical devices alone or in combination with drug therapies to treatheart failure conditions. Depending on the underlying condition beingmonitored or treated, medical devices such as cardiac monitors ordefibrillators may be surgically implanted or externally connected tothe patient. In some examples, the cardiac monitoring device may be anexternal wearable cardiac device for ambulatory use. Wearable medicaldevices, such as cardiac event monitoring devices, are used in clinicalor outpatient settings to monitor and record various physiologicalsignals for a patient. In some examples, a wearable cardiac monitoringand treatment device may be a wearable defibrillator configured tomonitor for cardiac arrhythmias and provide a treatment when alife-threatening arrhythmia is detected. Such a device can be worn bythe patient continuously to provide constant protection and subsequentlycan be refurbished for reuse by another patient. Systems and techniquesdisclosed herein improve the resiliency and serviceability of a devicecontroller for a wearable cardiac monitoring and treatment device.

This disclosure relates to a patient-worn cardiac monitoring andtreatment device that detects one or more treatable arrhythmias based onphysiological signals from a patient. The treatable arrhythmias includethose that may be treated by defibrillation pulses, such as ventricularfibrillation (VF) and shockable ventricular tachycardia (VT), or bypacing pulses, such as bradycardia, tachycardia, and asystole. Awearable medical device as disclosed herein monitors a patient'sphysiological conditions, e.g., cardiac signals, respiratory parameters,and patient activity, and delivers potentially life-saving treatment tothe patient. The medical device can include a plurality of sensingelectrodes that are disposed at various locations on the patient's bodyand configured to monitor the cardiac signals of the patient, such aselectrocardiogram (ECG) signals. In some implementations, the device canalso be configured to allow a patient to report his/her symptomsincluding one or more skipped beat(s), shortness of breath, lightheadedness, racing heart, fatigue, fainting, and chest discomfort. Thedevice determines an appropriate treatment for the patient based on thedetected cardiac signals and/or other physiological parameters prior todelivering a therapy to the patient. The device then causes one or moretherapeutic shocks, for example, defibrillating and/or pacing shocks, tobe delivered to the body of the patient. The wearable medical deviceincludes a plurality of therapy electrodes disposed on the patient'sbody and configured to deliver the therapeutic shocks.

In implementations, a garment portion of the wearable cardiac monitoringand treatment device is configured to be worn or otherwise secured aboutthe torso of the patient. A plurality of energy storage units areoperably connected to a therapy delivery circuit. The energy storageunits are configured to store energy for at least one therapeutic pulse.The therapy delivery circuit is configured to cause the delivery of theat least one therapeutic pulse via the plurality of therapy electrodes.In implementations, the energy storage units are electrically coupled byone or more cables to the plurality of therapy electrodes. For example,the one or more cables are electrically insulated and physicallyisolated from the skin of the patient and other components of the devicewhen the garment is assembled along with the plurality of energy storageunits, therapy delivery circuit, and therapy electrodes.

In some implementations, the wearable cardiac monitoring and treatmentdevice includes sensors configured to detect one or more physiologicalsignals of the patient. Such physiological sensors may include at leastone physiological sensor configured to monitor signals indicative ofcardiac activity, such as ECG signals and/or heart rate of the patient.For example, such ECG sensors can include one or more ECG electrodesconfigured to be in contact with the patient. The ECG electrodes can beplaced in contact with the patient's skin, for example, on the torso ofthe patient. In some examples, the one or more ECG electrodes are aplurality of ECG sensors in contact with a torso of the patient andconfigured to monitor an ECG signal of the patient.

The devices described here are prescribed to be worn continuously andfor long durations of time, often over the course of several weeks ormonths. For example, a prescribed duration can be a duration for which apatient is instructed by a caregiver to wear the device in compliancewith device use instructions. A device designed for an extended durationof wear may be prescribed for some or all of the designed duration asdescribed subsequently. A sudden cardiac arrest or other arrhythmiacondition can strike at any time and with little warning. Patients areencouraged to comply with the device use guidelines, including wearingthe device at all times including while showering or sleeping. In someimplementations, the continuous use can be substantially or nearlycontinuous in nature. That is, the wearable medical device may becontinuously used, except for sporadic periods during which the usetemporarily ceases (e.g., while the patient bathes, while the patient isrefit with a new and/or a different garment, while the battery ischarged/changed, while the garment is laundered, etc.). Suchsubstantially or nearly continuous use as described herein maynonetheless qualify as continuous use. In some implementations, thepatient may remove the wearable medical device for a short portion ofthe day (e.g., for half an hour to bathe). The devices, therefore, areconfigured to withstand impact from environmental factors and forcesassociated with daily continuous use by an ambulatory patient.Additionally, the devices are configured to allow for uncomplicatedassembly and disassembly during servicing for repair and/or refurbishingfor reuse by subsequent patients.

Further, the wearable medical device can be configured as a long term orextended use medical device. Such devices can be configured to be usedby the patient for an extended period of 24 hours or more, several days,weeks, months, or even years. Accordingly, the extended use can beuninterrupted until a physician or other caregiver provides specificprescription to the patient to stop use of the wearable medical device.For example, the wearable medical device can be prescribed for use by apatient for an extended period of at least one week. In an example, thewearable medical device can be prescribed for use by a patient for anextended period of at least 30 days. In an example, the wearable medicaldevice can be prescribed for use by a patient for an extended period ofat least one month. In an example, the wearable medical device can beprescribed for use by a patient for an extended period of at least twomonths. In an example, the wearable medical device can be prescribed foruse by a patient for an extended period of at least three months. In anexample, the wearable medical device can be prescribed for use by apatient for an extended period of at least six months. In an example,the wearable medical device can be prescribed for use by a patient foran extended period of at least one year.

In implementations, an example of a therapeutic medical device caninclude a short-term continuous monitoring defibrillator and/or pacingdevice, for example, a short-term outpatient wearable defibrillator. Forexample, such a short-term outpatient wearable defibrillator can beprescribed by a physician for patients presenting with syncope. Awearable defibrillator can be configured to monitor patients presentingwith syncope by, for example, analyzing the patient's cardiac activityfor aberrant patterns that can indicate abnormal physiological function.For example, such aberrant patterns can occur prior to, during, or afterthe onset of symptoms. In such an example implementation of theshort-term wearable defibrillator, the electrode assembly can beadhesively attached to the patient's skin and have a similarconfiguration as the in-hospital defibrillator previously described.

Regardless of the extended period of wear, the use of the wearablemedical device can include continuous or nearly continuous wear by thepatient as described above. For example, the continuous use can includecontinuous wear or attachment of the wearable medical device to thepatient. In implementations, the continuous attachment is through one ormore of the electrodes as described herein during both periods ofmonitoring and periods when the device may not be monitoring the patientbut is otherwise still worn by or otherwise attached to the patient.Continuous use can include continuously monitoring the patient while thepatient is wearing the device for cardiac-related information (e.g.,electrocardiogram (ECG) information, including arrhythmia information,heart vibrations, etc.) and/or non-cardiac information (e.g., bloodoxygen, the patient's temperature, glucose levels, tissue fluid levels,and/or lung vibrations). For example, the wearable medical device cancarry out its continuous monitoring and/or recording in periodic oraperiodic time intervals or times (e.g., every few minutes, hours, oncea day, once a week, or other interval set by a technician or prescribedby a caregiver). Alternatively or additionally, the monitoring and/orrecording during intervals or times can be triggered by a user action oranother event.

FIG. 1 illustrates an example medical device 100 that is external,ambulatory, and wearable by a patient, and configured to implement oneor more configurations described herein. For example, the medical device100 can be a non-invasive medical device configured to be locatedsubstantially external to the patient. Such a medical device 100 can be,for example, an ambulatory medical device that is capable of anddesigned for moving with the patient as the patient goes about his orher daily routine. For example, the medical device 100 as describedherein can be bodily-attached to the patient such as the LifeVest®wearable cardioverter defibrillator available from ZOLL® MedicalCorporation. In one example scenario, such wearable defibrillators canbe worn nearly continuously or substantially continuously for two tothree months at a time. During the period of time for which the patientwears the wearable defibrillator, the wearable defibrillator can beconfigured to continuously or substantially continuously monitor thevital signs of the patient and, upon determination that treatment isrequired, can deliver one or more therapeutic electrical pulses to thepatient. For example, such therapeutic shocks can be pacing,defibrillation, or transcutaneous electrical nerve stimulation (TENS)pulses.

The medical device 100 can include one or more of the following: agarment 111, one or more sensing electrodes 112 (e.g., ECG electrodes),one or more therapy electrodes 114 a and 114 b (collectively referred toas therapy electrodes 114), a medical device controller 120, aconnection pod 130, a patient interface pod 140, a belt 150, or anycombination of these. In some examples, at least some of the componentsof the medical device 100 can be configured to be affixed to the garment111 (or in some examples, permanently integrated into the garment 111),which can be worn about the patient's torso 5.

The medical device controller 120 (e.g., the controller 120) can beoperatively coupled to the sensing electrodes 112, which can be affixedto the garment 111, e.g., assembled into the garment 111 or removablyattached to the garment, e.g., using hook and loop fasteners. In someimplementations, the sensing electrodes 112 can be permanentlyintegrated into the garment 111. The controller 120 can be operativelycoupled to the therapy electrodes 114. For example, the therapyelectrodes 114 can also be assembled into the garment 111, or, in someimplementations, the therapy electrodes 114 can be permanentlyintegrated into the garment 111. The controller 120 contains hardwareand electronics to monitor and treat the patient. In implementations,the controller 120 can be serviced and/or refurbished for subsequent useby another patient. Implementations of the controller 120 describedherein, therefore, include one or more features directed towardfacilitating uncomplicated and successful disassembly and reassemblywithout compromising the ingress-protective assembly of the controller120.

Component configurations other than those shown in FIG. 1 are possible.For example, the sensing electrodes 112 can be configured to be attachedat various positions about the body of the patient. The sensingelectrodes 112 can be operatively coupled to the controller 120 throughthe connection pod 130. In some implementations, the sensing electrodes112 can be adhesively attached to the patient's body, such as to thetorso 5. In some implementations, the sensing electrodes 112 and atleast one of the therapy electrodes 114 can be included on a singleintegrated patch and adhesively applied to the patient's body.

The sensing electrodes 112 can be configured to detect one or morecardiac signals. Examples of such signals include ECG signals and/orother sensed cardiac physiological signals from the patient. In certainimplementations, the sensing electrodes 112 can include additionalcomponents such as accelerometers, acoustic signal detecting devices,and other measuring devices for recording additional parameters. Forexample, the sensing electrodes 112 can also be configured to detectother types of patient physiological parameters and acoustic signals,such as tissue fluid levels, heart vibrations, lung vibrations,respiration vibrations, patient movement, etc. Example sensingelectrodes 112 include a metal electrode with an oxide coating such astantalum pentoxide electrodes.

In some examples, the therapy electrodes 114 can also be configured toinclude sensors configured to detect ECG signals as well as otherphysiological signals of the patient. The connection pod 130 can, insome examples, include a signal processor configured to amplify, filter,and digitize these cardiac signals prior to transmitting the cardiacsignals to the controller 120. One or more of the therapy electrodes 114can be configured to deliver one or more therapeutic defibrillatingshocks to the torso 5 of the patient when the medical device 100determines that such treatment is warranted based on the signalsdetected by the sensing electrodes 112 and processed by the medicaldevice controller 120. Example therapy electrodes 114 can includeconductive metal electrodes such as stainless steel electrodes. Incertain implementations, each therapy electrode 114 includes one or moreconductive gel deployment devices configured to deliver conductive gelto the metal electrode prior to delivery of a therapeutic shock.

In implementations, each therapy electrode of the at least one pair oftherapy electrodes 114, 114 a, 114 b, has a conductive surface adaptedfor placement adjacent the patient's skin and has an impedance reducingmeans, e.g. an impedance reducing conductive gel, contained therein forreducing the impedance between a therapy electrode and the patient'sskin. In implementations, the patient-worn arrhythmia monitoring andtreatment device 100 may include gel deployment circuitry (e.g., the geldeployment circuit 205 of FIG. 2 ) configured to cause the delivery ofconductive gel substantially proximate to a treatment site (e.g., asurface of the patient's skin in contact with the therapy electrode 114)prior to delivering therapeutic shocks to the treatment site. Asdescribed in U.S. Pat. No. 9,008,801, titled “WEARABLE THERAPUETICDEVICE,” issued on Apr. 14, 2015 (hereinafter the “'801 Patent”), whichis hereby incorporated herein by reference in its entirety, the geldeployment circuitry may be configured to cause the delivery ofconductive gel immediately before delivery of the therapeutic shocks tothe treatment site, or within a short time interval, for example, withinabout 1 second, 5 seconds, 10 seconds, 30 seconds, or one minute beforedelivery of the therapeutic shocks to the treatment site. Such geldeployment circuitry, for example the gel deployment circuit 205 of FIG.2 , may be coupled to or integrated within a therapy electrode or othertherapy delivery device as a single unit. When a treatable cardiaccondition is detected and no patient response is received after deviceprompting, the gel deployment circuitry can be signaled to deploy theconductive gel. In some examples, the gel deployment circuitry may beconstructed as one or more separate and independent gel deploymentmodules. Such modules may be configured to receive removable and/orreplaceable gel cartridges (e.g., cartridges that contain one or moreconductive gel reservoirs). As such, the gel deployment circuitry may bepermanently disposed in the garment as part of the therapy deliverysystems, while the cartridges may be removable and/or replaceable.

In some implementations, the gel deployment modules may be implementedas gel deployment packs and include at least a portion of the geldeployment circuitry along with one or more gel reservoirs within thegel deployment pack. In such implementations, the gel deployment pack,including the one or more gel reservoirs and associated gel deploymentcircuitry may be removable and/or replaceable. In other examples, thegel deployment pack, including the one or more gel reservoirs andassociated gel deployment circuitry, and the therapy electrode can beintegrated into a therapy electrode assembly that can be removed andreplaced as a single unit either after use, or if damaged or broken.

FIG. 2 illustrates a sample component-level schematic of an examplemedical device controller 200, which could be an implementation of thedevice controller 120 of FIG. 1 , for example. As shown in FIG. 2 , themedical device controller 200 can include a therapy delivery circuit 202including a polarity switching component such as an H-bridge 228, a datastorage 204, a network interface 206, a user interface 208, at least onebattery 210, at least one capacitor 240, a sensor interface 211, analarm manager 213, and at least one processor 218. A patient monitoringmedical device can include a medical device controller 200 that includeslike components as those described above, but does not include at leastthe therapy delivery circuit 202 and at least one capacitor 240.

The therapy delivery circuit 202 can be coupled to one or more therapyelectrodes 214 configured to provide therapy to the patient (e.g.,therapy electrodes 114 as described above in connection with FIG. 1 ).For example, the therapy delivery circuit 202 can include, or beoperably connected to, circuitry components that are configured togenerate and provide the therapeutic shock. The circuitry components caninclude, for example, resistors, one or more capacitors, relays and/orswitches, an electrical bridge such as an H-bridge 228 (e.g., includinga plurality of insulated gate bipolar transistors or IGBTs that deliverand truncate a therapy pulse, as described in further detail below),voltage and/or current measuring components, and other similar circuitryarranged and connected such that the circuitry work in concert with thetherapy delivery circuit 202 and under control of one or more processors(e.g., processor 218) to provide, for example, one or more pacing ordefibrillation therapeutic pulses.

Pacing pulses can be used to treat cardiac arrhythmias such asbradycardia (e.g., in some implementations, less than 30 beats perminute) and tachycardia (e.g., in some implementations, more than 150beats per minute) using, for example, fixed rate pacing, demand pacing,anti-tachycardia pacing, and the like. Defibrillation pulses can be usedto treat ventricular tachycardia and/or ventricular fibrillation.

In implementations, the one or more capacitors include aparallel-connected capacitor bank consisting of one capacitor or aplurality of capacitors (e.g., two, three, four or more capacitors).These capacitors can be switched into a series connection duringdischarge for a defibrillation pulse. For example, four capacitors ofapproximately 500 μF can be used. In one implementation, the capacitorscan have between 500 to 2500 volt surge rating and can be charged inapproximately 5 to 30 seconds from a battery pack depending on theamount of energy to be delivered to the patient. Additionalimplementations of capacitor properties and arrangements on apatient-worn medical device are provided herein in subsequent sections.

In implementations, the gel deployment circuit 205 is coupled to theprocessor 218 and configured to cause the delivery of conductive gelimmediately before delivery of the therapeutic shocks to the treatmentsite, or within a short time interval, for example, within about 1second, 5 seconds, 10 seconds, 30 seconds, or one minute before deliveryof the therapeutic shocks to the treatment site. The gel deploymentcircuit 205 may be coupled to or integrated within a therapy electrode214 or other therapy delivery device as a single unit. When a treatablecardiac condition is detected and no patient response is received afterdevice prompting, the gel deployment circuit 205 can be signaled todeploy the conductive gel.

The data storage 204 can include one or more of non-transitory computerreadable media, such as flash memory, solid state memory, magneticmemory, optical memory, cache memory, combinations thereof, and others.The data storage 204 can be configured to store executable instructionsand data used for operation of the medical device controller 200. Incertain implementations, the data storage 204 can include executableinstructions that, when executed, are configured to cause the processor218 to perform one or more functions.

In some examples, the network interface 206 can facilitate thecommunication of information between the medical device controller 200and one or more other devices or entities over a communications network.For example, where the medical device controller 200 is included in anambulatory medical device (such as medical device 100), the networkinterface 206 can be configured to communicate with a remote computingdevice such as a remote server or other similar computing device. Thenetwork interface 206 can include communications circuitry fortransmitting data in accordance with a Bluetooth® wireless standard forexchanging such data over short distances to an intermediary device(s),e.g., a base station, a “hotspot” device, a smartphone, tablet, aportable computing device, and/or other devices in proximity of thewearable medical device. The intermediary device(s) may in turncommunicate the data to a remote server over a broadband cellularnetwork communications link. The communications link may implementbroadband cellular technology (e.g., 2.5G, 2.75G, 3G, 4G, 5G cellularstandards) and/or Long-Term Evolution (LTE) technology or GSM/EDGE andUMTS/HSPA technologies for high-speed wireless communication. In someimplementations, the intermediary device(s) may communicate with aremote server over a Wi-Fi™ communications link based on the IEEE 802.11standard.

In certain implementations, the user interface 208 can include one ormore physical interface devices such as input devices, output devices,and combination input/output devices and a software stack configured todrive operation of the devices. These user interface elements may rendervisual, audio, and/or tactile content. Thus, the user interface 208 mayreceive input or provide output, thereby enabling a user to interactwith the medical device controller 200. For example, the user interface208 can include one or a combination of a screen display, a touch screendisplay, LED and/or LCD display, LED lights, physical buttons, softbuttons (e.g., touch fields on a screen), one or more speakers, and/orone or more microphones.

The medical device controller 200 can also include at least one battery210 configured to provide power to one or more components integrated inthe medical device controller 200. The battery 210 can include arechargeable multi-cell battery pack. In one example implementation, thebattery 210 can include three or more 2000 mAh lithium ion cells thatprovide electrical power to the other device components within themedical device controller 200. For example, the battery 210 can provideits power output in a range of between 20 mA to 1000 mA (e.g., 40 mA)output and can support 24 hours, 48 hours, 72 hours, or more, of runtimebetween charges. In certain implementations, the battery capacity,runtime, and type (e.g., lithium ion, nickel-cadmium, or nickel-metalhydride) can be changed to best fit the specific application of themedical device controller 200.

The sensor interface 211 can be coupled to one or more sensorsconfigured to monitor one or more physiological parameters of thepatient. As shown, the sensors may be coupled to the medical devicecontroller 200 via a wired or wireless connection. The sensors caninclude one or more electrocardiogram (ECG) sensing electrodes 212(e.g., similar to sensing electrodes 112 as described above inconnection with FIG. 1 ), heart vibrations sensors 224, and tissue fluidmonitors 226 (e.g., based on ultra-wide band radiofrequency devices).

The ECG sensing electrodes 212 can monitor a patient's ECG information.For example, the ECG sensing electrodes 212 can include conventionalstick-on adhesive electrodes, conductive electrodes with stored geldeployment, e.g., metallic electrodes with stored conductive gelconfigured to be dispersed in the electrode-skin interface when needed,or dry electrodes, e.g., a metallic substrate with an oxide layer indirect contact with the patient's skin. The ECG sensing electrodes 212can be configured to measure the patient's ECG signals. The ECG sensingelectrodes 212 can transmit information descriptive of the ECG signalsto the sensor interface 211 for subsequent analysis.

The vibration sensors 224 can include heart vibration sensors to detecta patient's heart vibration information. For example, the vibrationssensors 224 can be configured to detect heart vibration values includingany one or all of S1, S2, S3, and S4. From these heart vibration values,certain electromechanical metrics may be calculated, including any oneor more of electromechanical activation time (EMAT), percentage of EMAT(% EMAT), systolic dysfunction index (SDI), and left ventricularsystolic time (LVST). The vibrations sensors 224 can include an acousticsensor configured to detect vibrations from a subject's cardiac systemand provide an output signal responsive to the detected heartvibrations. The vibrations sensors 224 can also include a multi-channelaccelerometer, for example, a three channel accelerometer configured tosense movement in each of three orthogonal axes such that patientmovement/body position can be detected. The vibrations sensors 224 cantransmit information descriptive of the heart vibrations information orpatient position/movement to the sensor interface 211 for subsequentanalysis.

The tissue fluid monitors 226 can use radio frequency (RF) basedtechniques to assess fluid levels and accumulation in a patient's bodytissue. For example, the tissue fluid monitors 226 can be configured tomeasure fluid content in the lungs, typically for diagnosis andfollow-up of pulmonary edema or lung congestion in heart failurepatients. The tissue fluid monitors 226 can include one or more antennasconfigured to direct RF waves through a patient's tissue and measureoutput RF signals in response to the waves that have passed through thetissue. In certain implementations, the output RF signals includeparameters indicative of a fluid level in the patient's tissue. Thetissue fluid monitors 226 can transmit information descriptive of thetissue fluid levels to the sensor interface 211 for subsequent analysis.

The sensor interface 211 can be coupled to any one or combination ofsensing electrodes/other sensors to receive other patient dataindicative of patient parameters. Once data from the sensors has beenreceived by the sensor interface 211, the data can be directed by theprocessor 218 to an appropriate component within the medical devicecontroller 200. For example, if heart data is collected by heartvibrations sensor 224 and transmitted to the sensor interface 211, thesensor interface 211 can transmit the data to the processor 218 which,in turn, relays the data to a cardiac event detector. The cardiac eventdata can also be stored on the data storage 204.

In certain implementations, the alarm manager 213 can be configured tomanage alarm profiles and notify one or more intended recipients ofevents specified within the alarm profiles as being of interest to theintended recipients. These intended recipients can include externalentities such as users (patients, physicians, and monitoring personnel)as well as computer systems (monitoring systems or emergency responsesystems). The alarm manager 213 can be implemented using hardware or acombination of hardware and software. For instance, in some examples,the alarm manager 213 can be implemented as a software component that isstored within the data storage 204 and executed by the processor 218. Inthis example, the instructions included in the alarm manager 213 cancause the processor 218 to configure alarm profiles and notify intendedrecipients using the alarm profiles. In other examples, alarm manager213 can be an application-specific integrated circuit (ASIC) that iscoupled to the processor 218 and configured to manage alarm profiles andnotify intended recipients using alarms specified within the alarmprofiles. Thus, examples of the alarm manager 213 are not limited to aparticular hardware or software implementation.

In some implementations, the processor 218 includes one or moreprocessors (or one or more processor cores) that each are configured toperform a series of instructions that result in manipulated data and/orcontrol the operation of the other components of the medical devicecontroller 200. In some implementations, when executing a specificprocess (e.g., cardiac monitoring), the processor 218 can be configuredto make specific logic-based determinations based on input datareceived, and be further configured to provide one or more outputs thatcan be used to control or otherwise inform subsequent processing to becarried out by the processor 218 and/or other processors or circuitrywith which processor 218 is communicatively coupled. Thus, the processor218 reacts to a specific input stimulus in a specific way and generatesa corresponding output based on that input stimulus. In some examplecases, the processor 218 can proceed through a sequence of logicaltransitions in which various internal register states and/or other bitcell states internal or external to the processor 218 may be set tologic high or logic low. The processor 218 can be configured to executea function stored in software. For example, such software may be storedin a data store coupled to the processor 218 and configured to cause theprocessor 218 to proceed through a sequence of various logic decisionsthat result in the function being executed. The various components thatare described herein as being executable by the processor 218 can beimplemented in various forms of specialized hardware, software, or acombination thereof. For example, the processor can be a digital signalprocessor (DSP) such as a 24-bit DSP processor. The processor can be amulti-core processor, e.g., having two or more processing cores. Theprocessor can be an Advanced RISC Machine (ARM) processor such as a32-bit ARM processor. The processor can execute an embedded operatingsystem, and include services provided by the operating system that canbe used for file system manipulation, display and audio generation,basic networking, firewalling, data encryption and communications.

In implementations, the controller 200 is configured to provide one ormore high energy shocks to the torso 5 of a patient, for example up tofive successive defibrillation shocks of 150J to 500J of energy to apatient experiencing a cardiac arrhythmia such as ventricularfibrillation or ventricular tachycardia. The controller 200 thereforeincludes considerations for avoiding patient exposure to high voltagecomponents and considerations for protecting the components therein fromdamage due to normal usage and ingress of fluid or other contaminantsduring a prescribed period of continuous wear.

In implementations, a serviceable, rugged, wearable cardiac treatmentdevice for continuous extended use by an ambulatory patient includes agarment (e.g. garment 111 of FIG. 1 ) configured to dispose therein aplurality of ECG sensing electrodes 212 and therapy electrodes 214 incontinuous extended contact with the torso 5 of the patient to monitorfor and treat a cardiac arrhythmia in the patient. The device caninclude an impact resistant, ingress-protected device controller (e.g.controller 120 or controller 200) configured to be in separableelectrical communication with the plurality of ECG sensing electrodes212 and therapy electrodes 214 in the garment.

In implementations, such as that of FIGS. 3 through 5 , the devicecontroller 200 includes an impact resistant energy core 300, a firstcircuit board 320, a second circuit board 330, and an ingress-protectivehousing 220, 220 a, 220 b configured to encapsulate the core 300 and thefirst and second circuit boards 320, 330 while still enabling removal ofthe impact-resistant energy core 300 and the first and second circuitboards 320, 330 during servicing. In implementations, theimpact-resistant energy core 300 includes a frame 310, and a least onecapacitor (e.g. capacitor 240). In implementations, the at least onecapacitor (e.g. capacitor 240) is permanently bonded to the frame 310such that the frame 310 along with the bonded at least one capacitorcomprises a unitary mass.

The frame 310 can be a lightweight structure manufactured from anon-conductive material such as a plastic and/or thermoplastic that isan electrical insulator. The characteristics of the material of theframe include maximizing dielectric strength, minimizing moistureabsorption and maximizing mechanical strength. For example, the frame310 can comprise at least one of polypropylene, Polyethylene (PE),Polyvinyl chloride (PVC), acrylic, polycarbonate, ULTEM 1000, NORYLN1150, and VALOX E45329. In implementations, the frame 310 exhibits highflexural strength in accordance with ASTM D638 and ISO527 standards, aresistance to absorbing moisture in accordance with ASTM D570 and ISO 62standards, a resistance to a wide range of bases and acids, a highresistance to fatigue in accordance with ASTM D790 and ISO178 standardsand a high impact strength in accordance with ASTM D256 and ISO 180/1Astandards. In implementations, the frame 310 can have a dielectricstrength in a range of about 500-900 V/mil in air. In implementationsthe frame can have a dielectric constant at 1 kHZ, 50% RH in a range ofabout 2.75-3.25. In implementations, the frame can have a dissipationfactor in a range of about 0.001-0.002 and a volume resistivity at 1/16of about 1.0×10({circumflex over ( )}17) Ohm-cm. In implementations theframe can have a moisture absorption in a range of about 0.05-0.25percent. In implementations the frame can have a tensile strength in arange of about 7,500-16,000 psi at 23 degrees Celsius (e.g., 73 degreesFahrenheit). In implementations the frame 310 can have a flexural yieldstrength in a range of about 10,000-25,000 psi. In implementations theframe 310 can have an impact strength (Izod, notched) in a range ofabout 1.0-2.0 ft-lb/in in accordance with the ASTM D256 standard. Inimplementations, the frame 310 can have a Rockwell hardness of 109 onthe “M” scale in accordance with ASTM standard D785. In implementations,the frame 310 can have an ultimate shear strength in a range of about10,000-20,000 psi. In examples, the materials noted above provide someor all of these properties. In one example the frame 310 can be made ofa material having the following properties shown in Table 1:

TABLE 1 Example Properties Units Value Water Absorption, @Equilibrium,73° F. % 0.25 (23 C.) Tensile Strength, Break, 73° F. psi 15,000Elongation, Break, 73° F., ASTMD638 % 60 Elongation, Yield, 73° F.,ASTMD638 % 7-8 Flexural Strength, 73° F. psi 22,000 Flexural Modulus,73° F. psi 475,000 Izod Impact Strength, Notched, 73° F. ft-lb/in 1.0Rockwell Hardness “M” Scale 110 Compressive Strength, ASTMD695 psi21,500 Compressive Modulus, ASTMD695 psi 475,000 Shear Strength,Ultimate psi 15,000 Dielectric Strength, In Air V/mil 700 DielectricConstant, 1 kHz, 50% RH — 3.10 Dissipation Factor 1 kHz, 50% RH, 73° F.— 0.0012 (23° C.) Volume Resistivity, 1/16″ ohm-cm 10 × 10¹⁷

Returning to the construction of the energy core 300, inimplementations, the frame 310 receives the at least one capacitor 240therein. As shown in FIGS. 6A and 6C, for example, the frame 310, 310′can comprise a pocket or well 312, 312′ sized, shaped, and/or configuredto receive the at least one capacitor 240, 240′ therein. In one example,as shown in FIGS. 6C through 7 the pocket 312 encapsulates the at leastone capacitor 240, 240 a, 240 b disposed therein by having solid wallsforming the pocket 312 and comprising a mouth 313 at an open end of thepocket 312 for receiving the at least one capacitor 240 therethrough. Inimplementations, the pocket 312 is at least as deep as the height H ofthe at least one capacitor 240 such that the at least one capacitor isat or below the mouth 313 of the pocket 312 when inserted. Because theframe 310 comprises a non-conductive, insulating material such asplastic, the pocket 312 isolates the high voltage at least one capacitor240 from other components of the controller 200.

In implementations, shown in FIGS. 6C through 7 , the high energy core300 includes a compound 315 disposed within the pocket 312 to immovablybind the at least one capacitor 240 to the frame 310 to form the unitarymass. In implementations, the compound 315 is an adhesive compound. Thecompound 315 can at least partially encapsulate the at least onecapacitor 240. In implementations, the compound 315 can include anelectrically insulating material (which may be dispersed in an adhesivemedium). The compound 315 can encase the at least one capacitor 240within the pocket 312. In implementations, the compound 315 can be anepoxy resin configured to be applied to the pocket in a liquid state andthat, when set after initial application, has a hardness rating of in arange of about 80-85 Shore D. In implementations, the compound 315 is alow viscosity epoxy (e.g., a viscosity of 400-700 centipoise (CPS)) thatoff-gasses and releases bubbles during a curing phase to release air andmaintain high voltage properties of the assembly. In implementations,the compound 315 is a viscose polymer that hardens at room temperature(e.g., around 25-55 F). In implementations, the compound 315 is at leastone of a marine grade epoxy and a UL listed epoxy. For example, thecompound 315 can be at least one of a WEST SYSTEM epoxy resin, such as105 Epoxy Resin, by WEST MARINE of Watsonville, CA. For example, thecompound 315 can be at least one of a TAP marine grade epoxy resin, suchas TAP 314 Epoxy Resin, by TAP PLASTICS, INC. of San Leandro, CA. Forexample, the compound can be at least one of a UL Listed epoxy, such asUL 94 V-0 Listed Epoxy, by EPDXIES, ETC. of CRANSTON, RI. Inimplementations, the such materials, as noted above, include dielectricmaterials that absorb moisture while providing voltage isolation of theat least one capacitor 240.

In one example, the compound 315 can have a tensile strength in a rangeof about 8,000-12,000 PSI, a compressive strength in a range of about20,000-24,000 PSI, and a flexural strength in a range of about14,000-20,000 PSI. In an example, the compound 315 is characterized byresistance to cracking when exposed to impact, vibration, and thermalshock and has a tensile strength in a range of 10,000 PSI, a compressivestrength of 22,000 PSI, and a flexural strength of 17,000 PSI. Inimplementations, the compound 315 has a dielectric strength less than orequal to 6.0 at both 1 kHz and 1 MHz, in accordance with ASTM D150. Inimplementations, the compound 315 has a dissipation factor, ordielectric loss, of less than or equal to 0.03 at 1 kHz and less than orequal to 0.05 at 1 MHz, in accordance with ASTM D150. Inimplementations, the compound 315 has a dialectic strength in a range ofabout 200-650 Volts/mil at about 25 degrees C., and a dielectricconstant of between about 3-6 and a dissipation factor of between about0.005-0.01 at about 25 degrees C. and 100 hz. In one example, thecompound 315 has a dielectric strength of 500 volts/mil, a dielectricconstant of 4.4, and a dissipation factor of 0.007 at about 25 degreesC. and 100 hz. In implementations, a volume resistivity the compound 315is greater than or equal to 0.1 teraohm-meter at about 25 degrees C. andgreater than or equal to 1.0 megaohm-meter at 125 degrees C., accordingto ASTM D257.

In implementations, the compound 315 can be applied at the mouth 313 ofthe pocket 312, across an exposed end of the at least one capacitor 240.In other implementations, the compound 315 can be applied to the bottomof the pocket 312 prior to insertion of the at least one capacitor 240.The compound 315 can be applied to the bottom of the pocket 312 beforeinsertion of the at least one capacitor 240 and across the mouth 313 ofthe pocket 312 and the exposed end of the at least one capacitor,adhering to both the at least one capacitor 240 and frame 310. Once set,the compound 315 immovably binds the at least one capacitor 240 to theframe 310. As such, the at least one capacitor 240 does not moverelative to the frame 310 and cannot be removed from the frame 310. Inthis manner, the at least one capacitor 240 and the frame 310 areassembled into a unitary mass with no moving parts once the compound 315is hardened. The impact resistant energy core 300 therefore is a solidmass comprising the at least one capacitor 240 immovably bonded andunable to be separated from to the frame 310. In view of at least theseaspects of its construction, the core 300 can be withstand impactswithout damaging the high voltage components confined therein. The core300 is resistant to impact damage and therefore designed to preventelectrical failure. By strengthening the core 300, the device 100 isable to be used by an ambulatory patient on a daily, continuous scheduleduring normal wear and tear activities without compromising the abilityof the device 100 to monitor the patient and deliver treatment whennecessary.

Although implementations of the energy core 300 described above includea frame 310 pocket 312 having continuous, unperforated, unbroken walls,other implementations can include a pocket having one or moresemi-perforated or scaffolding-style walls and/or no bottom wall toreduce the overall weight of the frame 310. In the implementation ofFIG. 6A, for example, the energy core 300′ includes a pocket 312′ havingtwo perforated sidewalls 311 a′, 311 b′. In such implementations, theassembled core 300′, such as that of FIG. 6B, includes additionalstructural elements configured to hold the at least one capacitor 240′to the frame 310′ until a curable, hardening compound is added to one orboth ends of the pocket 312′ to bind the at least one capacitor 240′ tothe frame 310′.

Returning to FIG. 7 , a cross section view of an embodiment of the core300 is depicted. In examples, the at least one capacitor 240 comprises afilm capacitor. In examples, such as that of FIG. 7 , the at least onecapacitor comprises at least two capacitors 240 a, 240 b. The at leasttwo capacitors 240 a, 240 b can be inserted into the pocket 312 in aside-by-side arrangement such that each of the two major planes of eachcapacitor is disposed adjacent a first sidewall 311 a and secondsidewall 311 b of the frame 310. In implementations, the at least twocapacitors are shorted together at both ends, the top and bottom ends,such that they are electrically in parallel and effectively act as onecapacitor in the circuitry of the controller 200. In examples, each ofthe at least two capacitors 240 a, 240 b are flattened film capacitorswith a maximum thickness of between 1 mm and 40 mm, a capacitance of atleast 50 microfarads, and a breakdown voltage rating between 1300 and2500 volts. In an example, the at least two capacitors 240 a, 240 b areeach an 81.25 μf film capacitor (e.g., about 162.5 μf combinedcapacitance) and have a combined surge rating of about 1600V.

In examples, the at least two capacitors 240 a, 240 b are shortedtogether at their aligned ends with a conductive plate, and the energycore 300 includes at least one wire extending from the at least twocapacitors 240 a, 240 b beyond the pocket 312 of the frame 310. The atleast two capacitors 240 a, 240 b can be connected in parallel, and theat least one wire can be connected to the first circuit board 320 tocommunicate with the at least one processor 218 and the therapy deliverycircuit 202. In implementations, the at least one wire includes twowires 340, 342, as shown in FIGS. 6C-D and 19A-B.

FIGS. 19A-B depict top and bottom views of an embodiment of twocapacitors 240 a, 240 b connected in parallel by first and secondconnectors 341 a, 341 b, such as conductive metal plates, electricallycoupled at each end to each of the two capacitors 240 a, 240 b. The endsof the first and second connectors 341 a, 341 b can be attached to thetwo capacitors 240 a, 240 b with conductive solder 347 a-b, 348 a-bapplied at top and bottom ends of each of the two capacitors 240 a, 240b such that the first and second connectors adhere to and bridge acrossthe top and bottom surfaces of the two capacitors 240 a, 240 b. A firstwire 340 of the can be electrically connected to a top end of the atleast one capacitor (e.g., the at least two capacitors 240 a, 240 b) anda second wire 342 can be electrically connected to a bottom end of theat least one capacitor. Although the adjectives “top” and “bottom” areapplied here in one configuration, the terminology could be applied inthe alternative. The example of FIGS. 19A and 19B further include anarrow 1900 indicating the direction of insertion of the two electricallycoupled capacitors 240 a, 240 b into a pocket 312 of a frame 310. Inthis example, the top end of the electrically coupled capacitors 240 a,240 b is closest to the mouth 313 of the pocket 312 when the energy core300 is fully assembled.

Because the second wire 342 is connected to the bottom end of theelectrically coupled capacitors 240 a, 240 b, the second wire 342 is atleast as long as the height H of the coupled capacitors 240 a, 240 b.For example, as shown in FIG. 7 , the second wire 342 is connected tothe shorted ends of the at least two capacitors 240 a, 240 b at thebottom of the pocket and threaded up the pocket 312, along and betweenthe at least two capacitors, toward the mouth 313 of the pocket 312. Asshown in FIG. 6D, the first wire 340 connected to the shorted ends ofthe at least two capacitors at the mouth 313 of the pocket 312 extendsfrom the pocket 312 adjacent the second wire 342. The first and secondwires 340, 342 can be prevented from disconnecting from the at least twocapacitors by the compound which flows around the first and second wires340, 342 when added to the energy core 300 and then hardens to immovablybind the wires 340, 342 to the unitary mass of the energy core 300. Thefirst and second wires 340, 342 are configured to be electricallycoupled to the first circuit board 320 affixed to the energy core 300.

In implementations, the at least one capacitor 240 occupies at least 50to 95 percent of a volume defined by the pocket 312 of the frame 310. Insome examples, the at least one capacitor 240 touches one or more walls311 of the pocket 312 and is electrically insulated by the highdielectric frame 310. In other examples, a gap of between 0.5 to 10 mmbetween one or more portions of the inner surface of the pocket 312 andthe at least one capacitor 240 disposed therein is configured to receivethe compound 315 such that the compound extends along the height H ofthe at least one capacitor between the at least one capacitor and theinner surface of the pocket 312. In implementations, such as that ofFIG. 7 , the compound flows around the second wire 342 that extends fromthe bottom of the at least one capacitor up through the pocket 312 tothe mouth 313 and hardens over time to secure the second wire 342 inthis configuration within the pocket 312.

The impact resistant energy core 300 therefore is a unitary mass of atleast one capacitor 240 bound to the frame 310 by a compound, such as aself-curing polymer, that immobilizes the at least one capacitor and theat least one wire electrically connected to the at least one capacitor.Additional components of the controller 200 are formed around the highenergy core 300, which provides a central, stable, solid, unbendable,and impact resistant foundation upon which to affix additional hardware.

As described previously with regard to FIGS. 3 through 5 , thecontroller 200 includes a first circuit board 320 and a second circuitboard 330. Although the first circuit board 320 and second circuit board330 are described herein as “first” and “second,” these terms are purelyillustrative for describing implementations of characteristics andfeatures associated with each of two circuit boards. The terms “first”and “second” could be applied in the alternative to each of the otherboard. In implementations, the first circuit board 320 and the secondcircuit board 330 include cardiac arrhythmia monitoring and therapycircuitry in electrical communication with the at least one capacitor240. The first circuit board 320 and second circuit board 330 can beaffixed to opposing sides of the impact-resistant energy core 300 in amanner to allow for separation from the impact-resistant energy core 300during servicing. In implementations, one or more releasable fastenersaffix the first and second circuit boards 320, 330 to opposing sides ofthe impact-resistant energy core 300. For example, the one or morereleasable fasteners can include one or more of screws, clamps, snaps,clips, and tape.

In examples, such as that of FIGS. 3 and 4 , the first and secondcircuit boards 320, 330 are affixed to the frame 310 with one or moreremovable screws. For example the first circuit board 320 is configuredto be affixed to the frame 310 with a plurality of screws 323 a-gconfigured to be inserted through receiving holes disposed about theperimeter of the first circuit board 320 and securely threaded intoreceiving threads of screw bosses 322 a-g disposed about the perimeterof the frame. Similarly the second circuit board 330 is configured to beaffixed to the frame with a plurality of screws 326 a-f configured to beinserted through receiving holes disposed about the perimeter of thefirst circuit board and securely threaded into receiving threads ofscrew bosses disposed about the perimeter of the frame, for example thescrew bosses 325 a-d of FIG. 6C. Although the implementation describedherein includes screws that can be inserted and tightened and loosenedand removed repeatedly, implementations of the controller 200 caninclude other releasable fasteners for retaining the first and secondcircuit boards 320, 330 on opposing sides of the energy core 300. Forexample, four spring loaded, press-fit retention clips can engage eachof the four sides of both major faces of the core and each of the firstand second circuit boards 320, 330 can be pressed into the retentionclips so that one of the two largest planar surfaces of each of thefirst and second circuit boards 320, 330 is face-to-face with one of thetwo largest planar surfaces of the energy core 300. In otherimplementations, double sided adhesive tape can be used to fasten eachof the first and second circuit boards 320, 330 to opposing sides of thecore 300. In some implementations, multiple modes of fastening (e.g.,screws and adhesive tape, or screws and epoxy material) may be used tosecure either or both of the first and second circuit boards 320, 330.

In implementations, the first circuit board 320 and second circuit board330 are configured to be disposed on opposing sides of the energy core300. The opposing sides are the largest planar surfaces of the energycore 300. In implementations the first and second circuit boards 320,330 each have two largest planar surfaces, one of each configured to bedisposed face-to-face on one of the opposing sides of the energy core300 such that the assembly of the energy core 300 and first and secondcircuit boards 320, 330 is compact. In implementations, 50-100% of aperiphery of each of the first and second circuit boards 320, 330contacts the energy core 300. In implementations, the first and secondcircuit boards 320, 330 are configured to be in electrical communicationvia a flexible connector 344 (FIG. 4 ) extending from the first circuitboard 320 to the second circuit board 330. The flexible connector 344can releasably connect to the first and second circuit boards 320, 330via a releasable connector 345 a, 345 b at each end and includes aflexible, flat ribbon cable 346 therebetween that wraps around an outeredge of the frame 310.

In implementations the first and second circuit boards 320, 330 overlapthe pocket 312 of the energy core 300 and the at least one capacitor 240therein. In implementations, such as those shown in FIGS. 8 and 9 , theframe 310 can include an overhang portion 327 extending beyond the mouth313 of the pocket 312 such that the entire length of the first circuitboard 320 is disposed on the entire length of the frame 310. Inimplementations, the second circuit board 330 is shorter than the firstcircuit board 320 and does not extend over the overhang portion 327. Theoverhang portion can include a sidewall neck down 328 a, 328 b such thata side wall of the overhang portion is shorter than a sidewall of thepocket. The overhang portion 327 therefore is configured to receivetherein a battery well, or compartment, formed in the rear shell 220 bof the ingress-protective housing 220. The well and rear housing will bedescribed subsequently with regard to implementations of theingress-protective housing 220.

Returning to FIGS. 8 and 9 , in implementations, the first circuit board320 includes hardware and circuitry supporting critical monitoring andtreatment functions and the second circuit board 330 includes hardwareand circuitry supporting non-critical functions that can be suspended orupdated, for example, without disturbing the critical monitoring andtreatment functions of the first circuit board 320. In examples, thefirst circuit board 320 comprises at least one processor (e.g.,processor 218) and high voltage circuitry (e.g., the therapy deliverycircuit 202) in communication with the at least one processor. Inimplementations, the at least one processor includes an arrhythmiadetection processor. In implementations the at least one processorincludes an arrhythmia detection processor and a therapy deliverycircuit 202. The first circuit board 320 can include thereon a speakerfor communicating alerts and critical notifications and instructions toa patient or caregiver, a health indicator LED, and at least one userresponse button 343, 343 a, 343 b with which a patient communicatesdirectly with the one or more processors on the first circuit board 320.For example, the patient can press and release the at least one userresponse button 343, 343 a, 343 b to indicate consciousness and delay atreatment in response to a notification of imminent shock. The at leastone user response button can be two response buttons 343 a, 343 b,located on the top of the housing 220, on opposite sides of the housing.In implementations the two opposed response buttons 343 a, 343 b can belocated at a central spot along the top of the controller 200. Such aconstruction can allow a patient to quickly reach down and place fingerson the response buttons without having to remember which end of thehousing 220 includes the at least one response button.

For example, as best shown in FIGS. 10A and 14A-B, the position of theat least one response button, e.g., two response buttons 343 a, 343 b,is centrally located at a top edge 219 of each of the front and rearshells 220 a, 220 b. In addition to their central location, the tworesponse buttons 343 a, 343 b can be recessed within the front and rearshells 220 a, 220 b such that a patient can quickly locate the responsebuttons and center their fingers upon the buttons for proper alignmentand application of force. The top edge 219 of the front and rear shellscan be notched and beveled to further facility efficient and accuratelocation of the response buttons. Additionally, as shown best in FIG.10A, the two response buttons 343 a, 343 b can be covered with anovermold 349 a, 349 b, such as at least one of rubber, silicone, and aurethane thermoplastic. The overmold can include textured elements, suchas one or more of raised nubs and ridges easily felt with a pad of afinger. When the controller 200 provides a warning of imminent shock, analert patient attempting to delay treatment may be startled and/orworried about quickly providing a response that delays treatment. Byplacing the buttons along an easily located edge of the housing 220, byrecessing them, and by covering them with a patterned overmold, apatient can easily use the sense of touch to quickly discern the buttons343 a, 343 a from the material of the front and rear shells 220 a, 220 band align their finger with the button for an effective application offorce.

In some implementations, alternatively or in addition, a patient canprovide a response to an alert of an arrhythmia detection by touching afield on the display 329. In an example, upon detecting a cardiacarrhythmia, the processor 218 of the device can output to the display329 an alert and/or notification. The alert and/or notification caninclude one or more capacitive fields configured to receive a touchinput or a pattern of touches from a responsive patient requesting adelay in treatment. In implementations, the processor 218 may require asequence of touches to verify that the patient is intentionallyrequesting a delay of treatment rather than accidentally touching abutton on the display 329.

While the first circuit board 320 includes the at least one processor218 for controlling alerts, treatment, and user interactions with thedisplay 329 and/or response buttons 343 a, 343 b, in implementations,the second circuit board 330 includes low voltage circuitry, includingat least one of communication circuitry (e.g., Cellular, WiFi, NFC),display and touch screen drivers, and one or more supercapacitors todrive a shutdown of applications running on one or more processors ofthe second circuit board 330. In implementations, such as that of FIG. 8, the first circuit board 320 includes a display mount 324 for receivingand retaining a display screen 329. In implementations the displayscreen 329 is in wired communication with the second circuit board 330and the display and touch screen drivers. In implementations, the secondcircuit board 330 includes the network interface 206. The networkinterface can include communications circuitry for transmitting data inaccordance with a BLUETOOTH wireless standard for exchanging such dataover short distances to an intermediary device(s) (e.g., a base station,a “hotspot” device, a smartphone, a tablet, a portable computing device,and/or other devices in proximity of the wearable medical device 100).In implementations, the network interface can communicate the data to aremote server over a broadband cellular network communications link. Thecommunications link may implement broadband cellular technology (e.g.,2.5G, 2.75G, 3G, 4G, 5G cellular standards) and/or Long-Term Evolution(LTE) technology or GSM/EDGE and UMTS/HSPA technologies for high-speedwireless communication. In some implementations, the network interfacecan communicate with a remote server over a WI-FI communications linkbased on the IEEE 802.11 standard.

As described above with regard to implementations, the first circuitboard 320 and second circuit board 330 and their associated hardware andcircuitry components are assembled around the energy core 300. Theenergy core 300 and the at least one capacitor 240 therein, therefore,form the core of the assembly of the controller 200, and the at leastone capacitor 240 is in electrical communication with the first circuitboard 320 and second circuit board 330 via at least one wire. As shownin FIG. 9 , in implementations, the at least one wire, e.g., first andsecond wires 340, 342, is in electrical communication with the firstcircuit board 320 such that the at least one capacitor 240 is incommunication with the at least one processor 218 and the high voltagecircuitry (e.g., therapy delivery circuit 202). In implementations, theat least one wire, e.g., first and second wires 340, 342, is soldered toa corresponding at least one contact, via, or through hole on the firstcircuit board 320. As depicted in FIG. 9 , the first and second circuitboards 320, 330 are affixed to opposing sides of the unitary mass of theenergy core and the at least one wire, e.g., first and second wires 340,342, extends from the energy core and is configured to attach to thefirst circuit board 320 within the confines of the frame 310. If theassembly of the energy core 300 and first and second circuit boards 320,330 is jostled during routine daily activities of the patient wearingthe device 100, the at least one wire is not under any tension or torqueand does not pull away from or separate from the first circuit board320. The at least one wire is therefore protected by being immobilizedrelative to the frame 310 and the first circuit board 320.

In embodiments of other devices, free standing electrolytic capacitorscan be mounted at one end to a circuit board. For example, a capacitorbank could include four freestanding electrolytic capacitorsindividually soldered to a circuit board such that four individual leadsare secured. If one of the freestanding electrolytic capacitorsdislodges and disconnects from the circuit board in response to impact,the entire capacitor bank would fail to provide sufficient energy fordelivering a therapeutic shock.

In contrast, the energy core 300 is the unitary mass at the core of theassembly of the controller 200. The controller 200 is formed around theat least one capacitor 240, for example two capacitors electricallyconnected in parallel. This reduces the number of wires requiringconnection to a circuit board and reduces the points of failure.Additionally, in implementations of the at least one capacitor 240including two capacitors connected in parallel and bound to thedielectric frame 310 by a compound, the two capacitors are immobilizedrelative to one another. Unlike freestanding capacitors, the at leastone capacitor (e.g., the two capacitors 240 a, 240 b of FIG. 7 ) arepart of the unitary mass of the energy core 300 and withstand impactassociated with daily activities of the patient and with beingaccidentally dropped, for example. The energy core 300 and at least onecapacitor 240 retained therein withstand the force of such impactwithout moving relative to one another and without moving relative tothe first and second circuit boards 320, 330 affixed to the energy core300.

In addition to including a rugged, impact-resistant energy core 300, thedevice 100 includes an ingress-protective housing 220 (hereinafterreferred to interchangeably as “the housing 220”). The housing 220 isconfigured to enable removal of the impact-resistant energy core 300 andthe first and second circuit boards 320, 330 during servicing. Thehousing 220 is configured to provide additional utility for withstandingdaily activities encountered during a patient's continuous use of thewearable device 100. An ambulatory patient can, for example, wear thedevice 100 and the controller 200 for hours, days, and weekscontinuously through activities such as walking, driving, sleeping, andbathing. By securely assembling the controller 200 around theimpact-resistant, unitary mass that is the energy core 300, the high andlow voltage components are securely affixed to withstand impact. Bysurrounding the controller with an ingress-protective housing 220, theenergy core 300, first circuit board 320, second circuit board 330, andother components and circuitry, such as the therapy delivery circuit 202and the user interface 208 (e.g. display and/or touch screen), are alsoprotected from environmental impact, such as liquid and dust.

In implementations, the impact-resistant energy core 300 and the affixedfirst and second circuit boards 320, 330 occupy between about 25%-90% ofa volume defined by the ingress-protective housing 220. This reduces theamount of volume in which dust or liquid could accumulate in addition toproviding a compact controller 200 more comfortably worn and handled bya patient. As depicted in the exploded views of FIGS. 5 and 10 , forexample, the ingress-protective housing comprises a rear shell 220 bconfigured to be disposed adjacent the second circuit board 330 and afront shell 220 a configured to be disposed adjacent the first circuitboard 320, the front shell 220 a mating with the rear shell 220 b in asealed configuration. Although the front shell 220 a and rear shell 220b are described herein as “front” and “rear,” these terms are purelyillustrative for describing implementations of characteristics andfeatures associated with each of two shells. The terms “front” and“rear” could be applied in the alternative.

In some implementations, the ingress-protected housing on the controller200 is water-resistant and has a predetermined ingress protection ratingcomplying with one or more of the rating levels set forth in IECstandard 60529. The liquid Ingress Protection rating can be one or moreof any level (e.g., levels 3 to 9) in which rating compliance tests arespecified in the standard. For example, to have a liquid ingressprotection rating level of 6, the ingress-protected housing 220 of thecontroller 200 shall protect against ingress of water provided by apowerful water jet. The powerful water jet test requires that thehousing of the controller 200 is sprayed from all practicable directionswith a stream of water from a test nozzle having a 12.5 mm diameter.Water sprays for 1 minute per square meter for a minimum of threeminutes at a volume of 100 liters per minute (+/−5 percent) so that acore of the stream of water is a circle of approximately 120 mmm indiameter at a distance of 2.5 meters from the nozzle. For example, tohave a rating level of 7, ingress of water shall not be possible whenthe housing of the controller 200 is completely immersed in water at adepth between 0.15 m and 1 m so that the lowest point of the housing ofthe controller 200 with a height less than 850 mm is located 1000 mmbelow the surface of the water and the highest point of a housing of thecontroller 200 with a height less than 850 mm is located 150 mm belowthe surface of the water. The controller 200 is immersed for a duration30 minutes, and the water temperature does not differ from that of thehousing of the controller 200 by more than 5K.

In implementations, the assembled ingress-protective housing 220 of thecontroller 200 can be constructed to be water-resistant and tested forsuch in accordance with the IEC 60529 standard for Ingress Protection.For instance, the controller 200 of the device 100 may be configured tohave a rating of level 7, protecting against immersion in water, up toone meter for thirty minutes. This enables a patient to wear the device100 in the bathtub or shower for uninterrupted, continuous use. Inimplementations, the controller 200 of the device 100 may be multiplecoded, including two or more levels. For example, the controller 200 ofthe device 100 can maintain a liquid Ingress Protection level of 7,protecting against temporary immersion, and a liquid Ingress Protectionlevel of 5, protecting against water jets. In implementations, theingress-protective housing includes an IP67 rating as set forth in IEC60529 Standard for Ingress Protection, and the controller 200 of thedevice 100 can maintain a liquid Ingress Protection level of 6,protecting against powerful water jets, and a liquid Ingress Protectionlevel of 7, protecting against temporary immersion. In examples, theingress-protective housing 220 of the controller 200 can comprise orconsist of at least one of neoprene, thermoformed plastic, or injectionmolded rubber or plastic, such as silicone or other biocompatiblesynthetic rubber.

The ingress-protected housing 220 of the controller 200 thereforeprotects the components thereunder (e.g., the processor 218, the therapydelivery circuit 202 including a polarity switching component such as anH-bridge 228, a data storage 204, a network interface 206, a userinterface 208, at least one battery 210, the sensor interface 211, analarm manager 213, and the at least one capacitors 240) from externalenvironmental impact, for example damage associated with solid particleingress, dust ingress, and/or moisture, water vapor or liquid ingress.Preventing ingress protects the electronic components of the device 100from short-circuiting or corrosion of moisture-sensitive electronics,for example, when a patient wears the device while showering.

In implementations, for example, the two interlocking shell portions,e.g. the front shell 220 a and rear shell 220 b, are configured to bemated in a sealed press fit. For example, as shown in FIGS. 10-11B, acompressible grommet, O-ring, or silicone seal 222 can be insertedbetween and/or about the mating surfaces such that ingress into theinterlocked shell portions is prevented. As shown in FIGS. 12 , forexample, a mating edge 221 a of the front shell 220 a and a mating edge221 b of the rear shell 220 b are configured to engage in a fittedinterlock when the front and rear shells 220 a, 220 b are mated to formthe ingress-protective housing 220. In implementations, at least one ofthe front and rear shells 220 a, 220 b includes a mortise in the matingedge and the other of the front and rear sells includes a projectionconfigured to engage the mortise. In implementations, such as theembodiment depicted in FIG. 12 , the front shell 220 a includes amortise 223 a on its mating edge 221 a and the rear shell 220 b includesa projection 223 b its mating edge 221 b configured to engage themortise of the mating edge 221 a front shell 220 a. The fitted interlockcan include a compressible silicone seal 222 disposed in the mortise 223a. For example, in implementations such as that shown in FIG. 11 , thecompressible silicone seal 222 has a cross sectional “H” profile andprovides resistance to taking a compression set such that the mated sealis tightly held and impervious to ingress of liquid and particulates. Inimplementations, the compressible silicone seal 222 has a durometer in arange of about 10 to 90 Shore A.

In implementations, the front and rear shells 220 a, 220 b can be heldin a sealed configuration by a press fit. Additionally or alternatively,in implementations, the front and rear shells 220 a, 220 b can be heldin a sealed configuration by one or more releasable fasteners. Forexample, as shown in the exploded assembly of FIGS. 5 , the front andrear shells 220 a, 220 b can be held in a sealed configuration byplurality of screws 232. In implementations, each of the plurality ofscrews 232 is configured to be inserted through each of a correspondingone of a plurality of holes in 234 in the front shell 220 a and engageeach of a corresponding one of a plurality of screw bosses 236 a-edisposed on an internal surface of the rear shell 220 b. Inimplementations, the housing 220 can include one or more clips 238disposed on one of the front and rear shells 220 a, 220 b for engagingthe other of the front and rear shells. In implementations such as thatof FIGS. 5 and 10 , the rear shell 220 b includes a clip 238 formed withthe rear shell as a flexible tab configured for holding the front shell220 a in mated engagement. In implementations, a single flexible tabalong one edge of the front shell 220 a or rear shell 220 b enablesmating the two shell portions of the housing 220 and holding themtogether while the plurality of holes 234 and corresponding plurality ofscrew bosses 236 are aligned for receiving the plurality of screwstherein. In implementations, the one or more clips 238 includes flexibletab about 0.5 to 1.0″ long. As shown in FIG. 7 , in implementations, theclip 238 can include a barbed free end configured to engage a retainingtrough 235 on the opposing shell.

Returning to FIG. 5 , the plurality of holes 234 in the front shell 220a can be sealed for maintaining an ingress protective rating of IP67 forthe housing 220. In implementations, each of the plurality of holes caninclude disposed therein rubber O-rings or grommets for sealing theholes 234 against ingress of liquid and particulate matter. Additionallyor alternatively, as shown in FIG. 5 , the housing 220 can include oneor more impervious plates configured to be secured over the one or morereleasable fasteners to prevent ingress of liquid and particulatematter. For example, the two plates 239 a, 239 b are configured to beattached to the front shell 220 a, thereby covering the holes 234 a-eand screws 232 a-e disposed therein. The one or more impervious plates,e.g. plates 239 a, 239 b, can be releasably attached to the exteriorsurface of the front shell 220 a by at least one of a press fitengagement, adhesive tape, snaps, or clips.

The one or more plates are releasably attached so that the releasablefasteners, e.g. the plurality of screws 232 a-e, are accessible forremoval from the housing 220 during servicing of the controller 200. Inimplementations, the front shell 220 a and the rear shell 220 b areconfigured to be separated for removal and replacement of at least theimpact-resistant energy core 300 and the affixed first and secondcircuit boards 320, 330. As shown in FIGS. 5 and 10 , the front shell220 a can include a touch screen 225 for interacting with the display329 and a speaker 227 for providing audible alarms, notifications, andinstructions to a patient and/or bystander. The first and second plates239 a, 239 b can be sized and shaped to follow the contours of the frontshell 220 a such that the touch screen 225 is accessible and uncoveredwith the first and second plates 239 a, 239 b affixed to the front shell220 a. Additionally, the at least one plate, e.g. plate 239 a, caninclude a plurality of apertures 241 configured to be positionedadjacent a plurality of speaker openings 242 in the front shell 220 afor unobstructed transmission of audible messages, alarms, andnotifications.

In implementations, the touch screen 225 is disposed on an interiorsurface of the front shell 220 a. The touch screen 225 can be affixed tothe front shell with an ingress-protective sealant such that theassembled ingress-protective housing 220 maintains an IP67 rating.Similarly, in implementations, the speaker 227 is disposed on aninterior surface of the front shell 220 a. The speaker 227 can be sealedwith an ingress-protective sealant such that the assembledingress-protective housing 220 maintains an IP67 rating. Additionally oralternatively, in implementations, the front shell 220 a can include aparticulate catching screen disposed across the speaker opening forpreventing ingress of particulate matter and liquid as prescribed by theIP67 rating. In implementations, the speaker 227 can be adhered to thefront shell 220 a by a curing adhesive, such as DP100 epoxy.Additionally or alternatively, the speaker can be adhered to the frontshell 220 a of the housing 220 by a double sided, pressure sensitiveadhesive tape. During servicing, such as cleaning or refurbishing, thehousing 220 can be disassembled and the front shell 220 a, along withthe used and potentially dusty and dirty touch screen 225 and speaker227, can be removed and replaced by a new assembly of the same elementsassembled and sealed similarly for maintaining an IP67 ingressprotection rating.

Any additional openings in the housing 220 can be similarly sealed toprevent ingress, such as any openings comprising user input buttons 343a, 343 b or electronics ports for mating with wired components. In someexamples, ports for receiving connectors therein can be sealed to thehousing 220 to prevent ingress. In implementations, theingress-protected housing 220 of the controller 200 includes at leastone ingress-protected receiving port 250 configured to receive at leastone connector 256 configured to electrically couple a plurality of ECGsensing electrodes 212 and therapy electrodes 214 to the controller 200.As previously described, the plurality of ECG sensing electrodes 212 andtherapy electrodes 214 can be in continuous extended contact with thetorso 5 of the patient to monitor for and treat a cardiac arrhythmia inthe patient. In implementations, the plurality of ECG sensing electrodes212 are configured to sense an ECG signal of the patient for furtheranalysis by at least one processor 218 disposed on the first circuitboard 320.

The controller 200 can be in separable electrical communication with theplurality of ECG sensing electrodes 212 and therapy electrodes 214. Theseparable electrical communication includes the connector 256 incommunication with the plurality of ECG sensing electrodes 212 andplurality of therapy electrodes 214. The connector 256 can be mated tothe ingress-protective housing 220 via the receiving port 250 such thatthe connector 256 and the plurality of ECG sensing electrodes 212 andplurality of therapy electrodes 214 are in electrical communication withone or both of the first and second circuit boards 320, 330. Thereceiving port 250 can be in electrical communication with one or bothof the first and second circuit boards 320, 330 via, for example, one ormore flexible cable connectors 255 as shown in FIG. 10 .

In implementations, the at least one ingress-protected receiving port250 can have an IP67 rating such that the device 100 can be connected tothe controller 200 and operable when a patient is showering or bathing,for example. As shown in FIGS. 10A-B. the ingress-protected receivingport 250 can include a grommet 251 configured to receive mating edges ofthe front and rear shells 220 a, 220 b in the assembled configuration ofthe ingress-protective housing 220. As shown in FIG. 10B, the grommet251 includes an upper flange 252 and a lower flange 253 and a well 254therebetween to receive the mating edges of the front and rear shellstherein. Additionally or alternatively, the grommet 251 can be sealed tothe assembled housing 220 with an ingress-protective sealant. Thegrommet 251 can be made of at least one of compressible rubber,polyurethane, silicone, and any thermoplastic elastomer, such that theintersection of the front and rear shells 220 a, 220 b with the grommet251 maintains an ingress-protection rating of IP67.

Turning now to FIGS. 14A-15 , additional openings in the housing 220 caninclude an opening for a battery connector 260. In implementations, therear shell 220 b further comprises a battery connector 260 extendingtherethrough for receiving a complimentary connector of a removablebattery 210. As depicted in FIG. 15 , the battery connector 260 can besealed to the housing 220 with an ingress-protective sealant and can bein wired communication with at least one processor 218 disposed on thefirst circuit board 320. The wired communication can include, forexample, a flexible cable connector 262 disposed between the energy core300 and an interior surface of the rear shell 220 b. The flexible cableconnector 262 therefore extends between the battery connector 260 andthe first circuit board 320 within the ingress protective housing 220thereby electrically connecting the battery connector 262 to the firstcircuit board 320. In implementations, the ingress-protective sealant isat least one of epoxy and pressure sensitive adhesive. For example, thebattery connector 260 can be affixed and sealed to the housing 220 by acompound such as an epoxy, e.g. DP100 epoxy. Additionally, oralternatively, the battery connector 260 can be affixed to the housingby pressure sensitive adhesive.

Returning to FIGS. 14A-B, in implementations, the rear shell 220 bdefines a compartment 270 configured to receive therein a removablebattery module 215 containing the battery 210. Outer surfaces of theremovable battery module 215 are flush with outer surfaces of theingress-protective housing 220 in a mated configuration. As previouslydescribed with regard to FIGS. 8 and 9 the frame 310 can include anoverhang portion 327 extending beyond the mouth 313 of the pocket 312such that the entire length of the first circuit board 320 is disposedon the entire length of the frame 310 while the relatively shortersecond circuit board 330 does not extend over the overhang portion 327.The overhang portion 327 therefore is configured to receive therein thecompartment 270 formed in the rear shell 220 b of the ingress-protectivehousing 220 for receiving the battery module 215. In implementations, alargest wall of the compartment nests within the overhang portion 327 ofthe frame 310 such that the wall of the compartment is substantiallyparallel to and adjacent to the portion of the first circuit board 320disposed on the overhang portion 327 of the frame 310.

While the overhang portion 327 provides support for and prevents flexureof the first circuit board 320, the device 100 also can includeadditional impact-resistant features for further ruggedizing thecontroller 200 to withstand wear, stress, and impact associated withdaily use. For example, as shown in FIG. 16 , the an interior surface ofthe front shell 220 a includes one or more impact-resistant features forprotecting the energy core 300 and the first and second circuit boards320, 330. In implementations, the front shell 220 a includes at least atleast one shock absorbing spacer 280 a-f configured to protect theimpact-resistant energy core 300 and the affixed first and secondcircuit boards 320, 330 from mechanical impact. Additionally oralternatively, the rear shell 220 b includes at least at least one shockabsorbing spacer configured to protect the impact-resistant energy core300 and the affixed first and second circuit boards 320, 330 frommechanical impact. If the controller 200 receives an impact, the energycore 300 and the first and second circuit boards 320, 330 deform intothe at least one shock absorbing spacer and the first and second circuitboards 320, 330 do not flex. This protects the high voltage and lowvoltage circuitry the components mounted to the first and second circuitboards 320, 330 against damage from forces or torque associated withboard flexure. The ingress-protective housing 220, therefore, isdesigned for rugged use and protects the components therein from damage.Simultaneously, the ingress-protective housing 220 enables servicing formaintenance and refurbishing of the controller 200 for use by anotherpatient.

In implementations, such as that of FIG. 20 , a method of constructing2000 a serviceable wearable cardiac treatment device controller 200 forcontinuous extended use by an ambulatory patient includes providingS2002 a frame 310 and inserting S2004 at least one capacitor 240 intothe frame. The at least one capacitor can be configured to holdelectrical charge sufficient to treat a cardiac arrhythmia of a patient.The method includes bonding S2006 the at least one capacitor to theframe such that the frame along with the bonded at least one capacitorcomprises an impact-resistant energy core 300. The method includesaffixing S2008 first and second circuit boards 320, 330 to opposingsides of the impact-resistant energy core in a manner to allow forseparation from the impact-resistant energy core during service. Thefirst and second circuit boards include cardiac arrhythmia monitoringand therapy circuitry in electrical communication with the at least onecapacitor. The method includes enclosing S2010 the energy core and theaffixed first and second circuit boards within an ingress-protectivehousing 220 configured to enable removal of the impact-resistant energycore and the first and second circuit boards during service.

In implementations, the frame 310 includes a pocket 312 for receivingtherein the at least one capacitor therein. Bonding the at least onecapacitor to the frame includes disposing S2007 a self-curing polymerwithin the pocket to at least partially encapsulate the at least onecapacitor and thereby immovably bind the at least one capacitor to theframe to form a unitary mass.

As described previously with regard to embodiments of the devicecontroller 200, the ingress-protective housing can include a rear shell220 b configured to be disposed adjacent the second circuit board and afront shell 220 a configured to be disposed adjacent the first circuitboard. In implementations of the method of constructing the serviceablewearable cardiac treatment device controller includes enclosing theenergy core and the affixed first and second circuit boards within aningress-protective housing by mating S2012 a front shell with the rearshell in a sealed configuration. The method can include securing S2013the front and rear shells in their sealed configuration with one or morereleasable fasteners 232 a-e.

Mating the front and rear shell can include engaging a mating edge ofthe front shell and a mating edge of the rear shell in a fittedinterlock to form the ingress-protective housing. In implementations,mating the front and rear shells comprises engaging a mortise 223 adisposed on a mating edge of one of the front and rear shells with aprojection 223 b disposed on a mating edge of the other of the one ofthe front and rear shells. The method can further include disposingS2011 a compressible silicone seal 222 in the mortise to achieve aningress-protective rating of at least one of IP6X, IPX6, and IPX7, where“X” is a variable representing a rating on a scale of 1 through 9 as setforth in the IEC 60529 Standard for Ingress Protection.

As described above, the teachings of the present disclosure can begenerally applied to external medical monitoring and/or treatmentdevices (e.g., devices that are not completely implanted within thepatient's body). External medical devices can include, for example,ambulatory medical devices that are capable of and designed for movingwith the patient as the patient goes about his or her daily routine. Anexample ambulatory medical device can be a wearable medical device suchas a wearable cardioverter defibrillator (WCD), a wearable cardiacmonitoring device, an in-hospital device such as an in-hospital wearabledefibrillator, a short-term wearable cardiac monitoring and/ortherapeutic device, and other similar wearable medical devices.

A wearable medical cardiac monitoring device is capable of continuoususe by the patient. Further, the wearable medical device can beconfigured as a long-term or extended use medical device. Such devicescan be designed to be used by the patient for a long period of time, forexample, a period of 24 hours or more, several days, weeks, months, oreven years. Accordingly, the long period of use can be uninterrupteduntil a physician or other caregiver provides specific prescription tothe patient to stop use of the wearable medical device. For example, thewearable medical device can be prescribed for use by a patient for aperiod of at least one week. In an example, the wearable medical devicecan be prescribed for use by a patient for a period of at least 30 days.In an example, the wearable medical device can be prescribed for use bya patient for a period of at least one month. In an example, thewearable medical device can be prescribed for use by a patient for aperiod of at least two months. In an example, the wearable medicaldevice can be prescribed for use by a patient for a period of at leastthree months. In an example, the wearable medical device can beprescribed for use by a patient for a period of at least six months. Inan example, the wearable medical device can be prescribed for use by apatient for a long period of at least one year. In some implementations,the extended use can be uninterrupted until a physician or othercaregiver provides specific instruction to the patient to stop use ofthe wearable medical device.

Regardless of the period of wear, the use of the wearable medical devicecan include continuous or nearly continuous wear by the patient aspreviously described. For example, the continuous use can includecontinuous wear of the wearable medical device by the patient.Continuous use can include continuously monitoring the patient while thepatient is wearing the device for cardiac-related information (e.g.,electrocardiogram (ECG) information, including arrhythmia information,cardiac vibrations, etc.) and/or non-cardiac information (e.g., bloodoxygen, the patient's temperature, glucose levels, tissue fluid levels,and/or pulmonary vibrations). For example, the wearable medical devicecan carry out its continuous monitoring and/or recording in periodic oraperiodic time intervals or times (e.g., every few minutes, hours, oncea day, once a week, or other interval set by a technician or prescribedby a caregiver). Alternatively or additionally, the monitoring and/orrecording during intervals or times can be triggered by a user action oranother event.

As noted above, the wearable medical device can be configured to monitorother physiologic parameters of the patient in addition to cardiacrelated parameters. For example, the wearable medical device can beconfigured to monitor, for example, pulmonary-vibrations (e.g., usingmicrophones and/or accelerometers), breath vibrations, sleep relatedparameters (e.g., snoring, sleep apnea), tissue fluids (e.g., usingradio-frequency transmitters and sensors), among others.

In implementations, the patient-worn arrhythmia monitoring and treatmentdevice 100 further includes a patient notification output via an outputdevice such as the display 329. In response to detecting one or moretreatable arrhythmia conditions, the processor 218 is configured toprompt the patient for a response by issuing the patient notificationoutput, which may be an audible output, tactile output, visual output,or some combination of any and all of these types of notificationoutputs. In the absence of a response to the notification output fromthe patient, the processor is configured to cause the therapy deliverycircuit 202 to deliver the one or more therapeutic pulses to thepatient.

FIG. 17 depicts an example of a process 1700 for determining whether toinitiate a therapy sequence and apply a therapeutic pulse to thethoracic region of a patient. In implementations, the processor 218,receives S1702 a patient ECG signal from the ECG sensing electrodes 212and analyzes S1704 the ECG signal for an arrhythmia condition. Theprocessor 218 determines S1706 whether the arrhythmia is lifethreatening condition and requires treatment. If the arrhythmia is notlife threatening, the processor 218 can cause a portion of the ECGsignal to be stored in memory for later analysis and continue to monitorthe patient ECG signal. If the arrhythmia is life threatening, theprocessor 218 provides S1708 a patient notification output and requestsS1710 a patient response to the provided notification output. Inimplementations, the patient responds to an alert by interacting with auser interface (e.g., the user interface 208 of FIG. 2 ), whichincludes, for example, one or more buttons (e.g. the at least one button343 a, 343 b of the device 100 as shown in FIGS. 8-10 ) or touch screeninterface buttons with haptic feedback (e.g., touch screen buttons onthe touch screen 225 of the controller 200 and/or a second at least oneresponse button of a wearable article (e.g. an arm band or wrist wornarticle comprising at least one of a mechanically-actuatable button, atouch screen interface, and at least one touch screen button on a userinterface of the wearable article) or like devices, such as smartphonesrunning user-facing interactive applications). The response may be, forexample, pressing one or more buttons in a particular sequence or for aparticular duration. The processor 218 determines S1712 whether thepatient response was received. If the patient responds to thenotification output, the processor 218 is notified that the patient isconscious and returns to a monitoring mode, thereby delaying delivery ofa therapeutic defibrillation or pacing shock. If the patient isunconscious and unable to respond to the provided alert, the processor218 initiates S1714 the therapy sequence and treats S1716 the patientwith the delivery of energy to the thoracic region of the patient. Inimplementations, if a user response button is pressed for longer than athreshold duration (e.g. longer than 5 seconds), the processor 218instructs the device to prompt the patient to release the button. If theuser response button is not released the device will return to a stateof imminent therapy delivery and will alert the patient to the imminentshock.

In examples, the medical device can include physiological sensorsconfigured to detect one or more cardiac signals. Examples of suchsignals include ECG signals and/or other sensed cardiac physiologicalsignals from the patient. In certain implementations, the physiologicalsensors can include additional components such as accelerometers,vibrational sensors, and other measuring devices for recordingadditional parameters. For example, the physiological sensors can alsobe configured to detect other types of patient physiological parametersand vibrational signals, such as tissue fluid levels, cardio-vibrations,pulmonary-vibrations, respiration-related vibrations of anatomicalfeatures in the airway path, patient movement, etc. Examplephysiological sensors can include ECG sensors including a metalelectrode with an oxide coating such as tantalum pentoxide electrodes,as described in, for example, U.S. Pat. No. 6,253,099 entitled “CardiacMonitoring Electrode Apparatus and Method,” the content of which isincorporated herein by reference.

In examples, the physiological sensors can include a heart rate sensorfor detecting heart beats and monitoring the heart rate of the patient.For instance, such heart rate sensors can include the ECG sensors andassociated circuitry described above. In some examples, the heart ratesensors can include a radio frequency based pulse detection sensor or apulse oximetry sensor worn adjacent an artery of the patient. Inimplementations, the heart rate sensor can be worn about the wrist of apatient, for example, incorporated on and/or within a watch or abracelet. In some examples, the heart rate sensor can be integratedwithin a patch adhesively coupled to the skin of the patient over anartery.

In some examples, the treatment electrodes 114, 214 can also beconfigured to include sensors configured to detect ECG signals as wellas other physiological signals of the patient. The ECG data acquisitionand conditioning circuitry is configured to amplify, filter, anddigitize these cardiac signals. One or more of the treatment electrodes114, 214 can be configured to deliver one or more therapeuticdefibrillating shocks to the body of the patient when the medical devicedetermines that such treatment is warranted based on the signalsdetected by the ECG sensing electrodes 112, 212 and processed by theprocessor 218. Example treatment electrodes 114, 214 can includeconductive metal electrodes such as stainless steel electrodes thatinclude, in certain implementations, one or more conductive geldeployment devices configured to deliver conductive gel to the metalelectrode prior to delivery of a therapeutic shock.

In some implementations, medical devices as described herein can beconfigured to switch between a therapeutic medical device and amonitoring medical device that is configured to only monitor a patient(e.g., not provide or perform any therapeutic functions). Thetherapeutic elements can be deactivated (e.g., by means or a physical ora software switch), essentially rendering the therapeutic medical deviceas a monitoring medical device for a specific physiologic purpose or aparticular patient. As an example of a software switch, an authorizedperson can access a protected user interface of the medical device andselect a preconfigured option or perform some other user action via theuser interface to deactivate the therapeutic elements of the medicaldevice.

FIG. 2 illustrates an example component-level view of the controller200. As shown in FIG. 7 , the controller 200 can include a therapydelivery circuit 202 including a polarity switching component such as anH-bridge 228, a data storage 204, a network interface 206, a userinterface 208 at least one battery 210, a sensor interface 211 thatincludes, for example, an ECG data acquisition and conditioning circuit,an alarm manager 213, least one processor 218, and one or morecapacitors 240. A patient monitoring medical device can includecomponents like those described with regard to FIG. 7 , but does notinclude the therapy delivery circuit 202.

The therapy delivery circuit 202 is coupled to two or more treatmentelectrodes configured to provide therapy to the patient. For example,the therapy delivery circuit 202 includes, or is operably connected to,circuitry components that are configured to generate and provide thetherapeutic shock. The circuitry components include, for example,resistors, one or more capacitors, relays and/or switches, an electricalbridge such as an H-bridge 228 (e.g., an H-bridge including a pluralityof insulated gate bipolar transistors or IGBTs that deliver and truncatea therapy pulse), voltage and/or current measuring components, and othersimilar circuitry arranged and connected such that the circuitry work inconcert with the therapy delivery circuit and under control of one ormore processors (e.g., processor 218) to provide, for example, one ormore pacing or defibrillation therapeutic pulses.

Pacing pulses can be used to treat cardiac arrhythmias such asbradycardia (e.g., in some implementations, less than 30 beats perminute) and tachycardia (e.g., in some implementations, more than 150beats per minute) using, for example, fixed rate pacing, demand pacing,anti-tachycardia pacing, and the like. Defibrillation pulses can be usedto treat ventricular tachycardia and/or ventricular fibrillation.

In implementations, each of the treatment electrodes 114, 214 has aconductive surface adapted for placement adjacent the patient's skin andhas an impedance reducing means contained therein or thereon forreducing the impedance between a treatment electrode and the patient'sskin. In implementations, each of the treatment electrodes can include aconductive impedance reducing adhesive layer, such as a breathableanisotropic conductive hydrogel disposed between the treatmentelectrodes and the torso of the patient. In implementations, apatient-worn cardiac monitoring and treatment device may include geldeployment circuitry configured to cause the delivery of conductive gelsubstantially proximate to a treatment site (e.g., a surface of thepatient's skin in contact with the treatment electrode 114) prior todelivering therapeutic shocks to the treatment site. As described inU.S. Pat. No. 9,008,801, titled “WEARABLE THERAPUETIC DEVICE,” issued onApr. 14, 2015 (hereinafter the “'801 Patent”), which is incorporatedherein by reference in its entirety, the gel deployment circuitry can beconfigured to cause the delivery of conductive gel immediately beforedelivery of the therapeutic shocks to the treatment site, or within ashort time interval, for example, within about 1 second, 5 seconds, 10seconds, 30 seconds, or one minute before delivery of the therapeuticshocks to the treatment site. Such gel deployment circuitry can becoupled to or integrated with each of the treatment electrodes 114, 214.

When a treatable cardiac condition is detected and no patient responseis received after device prompting, the gel deployment circuitry can besignaled to deploy the conductive gel. In some examples, the geldeployment circuitry can be constructed as one or more separate andindependent gel deployment modules. Such modules can be configured toreceive removable and/or replaceable gel cartridges (e.g., cartridgesthat contain one or more conductive gel reservoirs). As such, the geldeployment circuitry can be permanently disposed in the device as partof the therapy delivery systems, while the cartridges can be removableand/or replaceable.

In some implementations, the gel deployment modules can be implementedas gel deployment packs and include at least a portion of the geldeployment circuitry along with one or more gel reservoirs within thegel deployment pack. In such implementations, the gel deployment pack,including the one or more gel reservoirs and associated gel deploymentcircuitry can be removable and/or replaceable. In some examples, the geldeployment pack, including the one or more gel reservoirs and associatedgel deployment circuitry, and the treatment electrode can be integratedinto a treatment electrode assembly that can be removed and replaced asa single unit either after use, or if damaged or broken.

Continuing with the description of the example medical device of FIG. 2, in implementations, the at least one capacitors 240 is a plurality ofcapacitors (e.g., two, three, four or more capacitors) comprising acapacitor bank. The plurality of capacitors can be switched into aseries connection during discharge for a defibrillation pulse. Forexample, four capacitors of approximately 650 μF can be used. In oneimplementation, the capacitors can have between 200 to 2500 volt surgerating and can be charged in approximately 5 to 30 seconds from abattery 210 depending on the amount of energy to be delivered to thepatient. In another example, the at least one capacitor is twocapacitors shorted together in parallel electrical communication. Thetwo capacitors can have combined capacitance of 162.5 μF and a voltsurge rating of between 1000 and 2000 V.

For example, each defibrillation pulse can deliver between 60 to 400joules (J) of energy. In some implementations, the defibrillating pulsecan be a biphasic truncated exponential waveform, whereby the signal canswitch between a positive and a negative portion (e.g., chargedirections). An amplitude and a width of the two phases of the energywaveform can be automatically adjusted to deliver a predetermined energyamount.

The data storage 204 can include one or more of non-transitory computerreadable media, such as flash memory, solid state memory, magneticmemory, optical memory, cache memory, combinations thereof, and others.The data storage 204 can be configured to store executable instructionsand data used for operation of the medical device. In certainimplementations, the data storage 204 can include executableinstructions that, when executed, are configured to cause the processor218 to perform one or more functions.

In some examples, the network interface 206 can facilitate thecommunication of information between the medical device and one or moreother devices or entities over a communications network. For example,the network interface 206 can be configured to communicate with a remotecomputing device such as a remote server or other similar computingdevice. The network interface 206 can include communications circuitryfor transmitting data in accordance with a BLUETOOTH wireless standardfor exchanging such data over short distances to an intermediarydevice(s) (e.g., a base station, a “hotspot” device, a smartphone, atablet, a portable computing device, and/or other devices in proximityof the wearable medical device 100). The intermediary device(s) may inturn communicate the data to a remote server over a broadband cellularnetwork communications link. The communications link may implementbroadband cellular technology (e.g., 2.5G, 2.75G, 3G, 4G, 5G cellularstandards) and/or Long-Term Evolution (LTE) technology or GSM/EDGE andUMTS/HSPA technologies for high-speed wireless communication. In someimplementations, the intermediary device(s) may communicate with aremote server over a WI-FI communications link based on the IEEE 802.11standard.

In certain implementations, the user interface 208 can include one ormore physical interface devices such as input devices, output devices,and combination input/output devices and a software stack configured todrive operation of the devices. These user interface elements may rendervisual, audio, and/or tactile content. Thus, the user interface 208 mayreceive input or provide output, thereby enabling a user to interactwith the medical device. In some implementations, the user interface 208can be implemented as a wearable article or as a hand-held userinterface device (for example, wearable articles including the patientinterface pod 140 of FIG. 1 and the wrist and arm worn remote devices.)For instance, a hand-held user interface device can be a smartphone orother portable device configured to communicate with the processor 218via the network interface 206. In an implementation, the hand-held userinterface device may also be the intermediary device for facilitatingthe transfer of information from the device to a remote server.

As described, the medical device can also include at least one battery210 configured to provide power to one or more components, such as theat least one capacitor 240. The battery 210 can include a rechargeablemulti-cell battery pack. In one example implementation, the battery 210can include three or more 2200 mAh lithium ion cells that provideelectrical power to the other device components. For example, thebattery 210 can provide its power output in a range of between 20 mA to1000 mA (e.g., 40 mA) output and can support 24 hours, 48 hours, 72hours, or more, of runtime between charges. As previously described indetail, in certain implementations, the battery capacity, runtime, andtype (e.g., lithium ion, nickel-cadmium, or nickel-metal hydride) can bechanged to best fit the specific application of the medical device.

The sensor interface 211 can be coupled to one or more sensorsconfigured to monitor one or more physiological parameters of thepatient. As shown in FIG. 2 the sensors can be coupled to the medicaldevice controller (e.g., processor 218) via a wired or wirelessconnection. The sensors can include one or more sensing electrodes(e.g., ECG sensing electrode 212), vibrations sensors 224, and tissuefluid monitors 226 (e.g., based on ultra-wide band radiofrequencydevices). For example, the sensor interface 211 can include ECGcircuitry (such as ECG acquisition and conditioning circuitry) and/oraccelerometer circuitry, which are each configured to receive andcondition the respective sensor signals.

The sensing electrodes can monitor, for example, a patient's ECGinformation. For example, the sensing electrodes of FIG. 2 can be ECGsensing electrodes 212 and can include conductive electrodes with storedgel deployment (e.g., metallic electrodes with stored conductive gelconfigured to be dispersed in the electrode-skin interface when needed),conductive electrodes with a conductive adhesive layer, or dryelectrodes (e.g., a metallic substrate with an oxide layer in directcontact with the patient's skin). The sensing electrodes can beconfigured to measure the patient's ECG signals. The sensing electrodescan transmit information descriptive of the ECG signals to the sensorinterface 211 for subsequent analysis.

The vibrations sensors 224 can detect a patient's cardiac or pulmonary(cardiopulmonary) vibration information. For example, thecardiopulmonary vibrations sensors 224 can be configured to detectcardio-vibrational biomarkers in a cardio-vibrational signal, includingany one or all of S1, S2, S3, and S4 cardio-vibrational biomarkers. Fromthese cardio-vibrational biomarkers, certain electromechanical metricscan be calculated, including any one or more of electromechanicalactivation time (EMAT), percentage of EMAT (% EMAT), systolicdysfunction index (SDI), left ventricular diastolic perfusion time(LDPT), and left ventricular systolic time (LVST). The cardiopulmonaryvibrations sensors 224 may also be configured to detect heart wallmotion, for example, by placement of the cardiopulmonary vibrationssensor 224 in the region of the apical beat.

The vibrations sensors 224 can include an acoustic sensor configured todetect vibrations from a subject's cardiac or pulmonary(cardiopulmonary) system and provide an output signal responsive to thedetected vibrations of the targeted organ. For instance, in someimplementations, the vibrations sensors 224 are able to detectvibrations generated in the trachea or lungs due to the flow of airduring breathing. The vibrations sensors 224 can also include amulti-channel accelerometer, for example, a three channel accelerometerconfigured to sense movement in each of three orthogonal axes such thatpatient movement/body position can be detected. The vibrations sensors224 can transmit information descriptive of the cardiopulmonaryvibrations information or patient position/movement to the sensorinterface 211 for subsequent analysis.

The tissue fluid monitors 226 can use radio frequency (RF) basedtechniques to assess changes of accumulated fluid levels over time. Forexample, the tissue fluid monitors 226 can be configured to measurefluid content in the lungs (e.g., time-varying changes and absolutelevels), for diagnosis and follow-up of pulmonary edema or lungcongestion in heart failure patients. The tissue fluid monitors 226 caninclude one or more antennas configured to direct RF waves through apatient's tissue and measure output RF signals in response to the wavesthat have passed through the tissue. In certain implementations, theoutput RF signals include parameters indicative of a fluid level in thepatient's tissue. The tissue fluid monitors 226 can transmit informationdescriptive of the tissue fluid levels to the sensor interface 211 forsubsequent analysis.

The sensor interface 211 can be coupled to any one or combination ofsensing electrodes/other sensors to receive other patient dataindicative of patient parameters. Once data from the sensors has beenreceived by the sensor interface 211, the data can be directed by theprocessor 218 to an appropriate component within the medical device. Forexample, if cardiac data is collected by the cardiopulmonary vibrationssensor 224 and transmitted to the sensor interface 211, the sensorinterface 211 can transmit the data to the processor 218 which, in turn,relays the data to a cardiac event detector. The cardiac event data canalso be stored on the data storage 204.

An alarm manager 213 can be configured to manage alarm profiles andnotify one or more intended recipients of events specified within thealarm profiles as being of interest to the intended recipients. Theseintended recipients can include external entities such as users (e.g.,patients, physicians, other caregivers, patient care representatives,and other authorized monitoring personnel) as well as computer systems(e.g., monitoring systems or emergency response systems). The alarmmanager 213 can be implemented using hardware or a combination ofhardware and software. For instance, in some examples, the alarm manager213 can be implemented as a software component that is stored within thedata storage 204 and executed by the processor 218. In this example, theinstructions included in the alarm manager 213 can cause the processor218 to configure alarm profiles and notify intended recipients accordingto the configured alarm profiles. In some examples, alarm manager 213can be an application-specific integrated circuit (ASIC) that is coupledto the processor 218 and configured to manage alarm profiles and notifyintended recipients using alarms specified within the alarm profiles.Thus, examples of alarm manager 213 are not limited to a particularhardware or software implementation.

In some implementations, the processor 218 includes one or moreprocessors (or one or more processor cores) that each are configured toperform a series of instructions that result in manipulated data and/orcontrol the operation of the other components of the medical device. Insome implementations, when executing a specific process (e.g., cardiacmonitoring), the processor 218 can be configured to make specificlogic-based determinations based on input data received, and be furtherconfigured to provide one or more outputs that can be used to control orotherwise inform subsequent processing to be carried out by theprocessor 218 and/or other processors or circuitry with which processor218 is communicatively coupled. Thus, the processor 218 reacts to aspecific input stimulus in a specific way and generates a correspondingoutput based on that input stimulus. In some example cases, theprocessor 218 can proceed through a sequence of logical transitions inwhich various internal register states and/or other bit cell statesinternal or external to the processor 218 can be set to logic high orlogic low. The processor 218 can be configured to execute a functionstored in software. For example, such software can be stored in a datastore coupled to the processor 218 and configured to cause the processor218 to proceed through a sequence of various logic decisions that resultin the function being executed. The various components that aredescribed herein as being executable by the processor 218 can beimplemented in various forms of specialized hardware, software, or acombination thereof. For example, the processor can be a digital signalprocessor (DSP) such as a 24-bit DSP processor. The processor 218 can bea multi-core processor, e.g., a processor having two or more processingcores. The processor can be an Advanced RISC Machine (ARM) processorsuch as a 32-bit ARM processor or a 64-bit ARM processor. The processorcan execute an embedded operating system and include services providedby the operating system that can be used for file system manipulation,display & audio generation, basic networking, firewalling, dataencryption and communications.

In implementations, the therapy delivery circuit 202 includes, or isoperably connected to, circuitry components that are configured togenerate and provide the therapeutic shock. As described previously, thecircuitry components include, for example, resistors, one or morecapacitors 240, relays and/or switches, an electrical bridge such as anH-bridge 228 (e.g., an H-bridge circuit including a plurality ofswitches, (e.g. insulated gate bipolar transistors or IGBTs, siliconcarbide field effect transistors (SiC FETs), metal-oxide semiconductorfield effect transistors (MOSFETS), silicon-controlled rectifiers(SCRs), or other high current switching devices)), voltage and/orcurrent measuring components, and other similar circuitry componentsarranged and connected such that the circuitry components work inconcert with the therapy delivery circuit 202 and under control of oneor more processors (e.g., processor 218) to provide, for example, one ormore pacing or defibrillation therapeutic pulses.

In implementations, the device further includes a source of electricalenergy, for example, the one or more capacitors 240, that stores andprovides energy to the therapy delivery circuit 202. The one or moretherapeutic pulses are defibrillation pulses of electrical energy, andthe one or more treatable arrhythmias include ventricular fibrillationand ventricular tachycardia. In implementations, the one or moretherapeutic pulses are biphasic exponential pulses. Such therapeuticpulses can be generated by charging the one or more capacitors 240 anddischarging the energy stored in the one or more capacitors 240 into thepatient. For example, the therapy delivery circuit 202 can include oneor more power converters for controlling the charging and discharging ofthe one or more capacitors 240. In some implementations, the dischargeof energy from the one or more capacitors 240 can be controlled by, forexample, an H-bridge that controls the discharge of energy into the bodyof the patient, like the H-bridge circuit described in U.S. Pat. No.6,280,461, titled “PATIENT-WORN ENERGY DELIVERY APPARATUS,” issued onAug. 28, 2001, and U.S. Pat. No. 8,909,335, titled “METHOD AND APPARATUSFOR APPLYING A RECTILINEAR BIPHASIC POWER WAVEFORM TO A LOAD,” issued onDec. 9, 2014, each of which is hereby incorporated herein by referencein its entirety.

As shown in the embodiment to FIG. 18 , an H-bridge 1228 is electricallycoupled to a capacitor bank 1402 including four capacitors 1135 a-d thatare charged in parallel at a preparation phase 1227 a and discharged inseries at a treatment phase 1227 b. In some implementations, thecapacitor bank 1402 can include more or fewer than four capacitors 1135.During the treatment phase 1227 b, the H-bridge 1228 applies atherapeutic pulse that causes current to flow through the torso 5 of thepatient 101 in desired directions for desired durations. The H-bridge1228 includes H-bridge switches 1229 a-d that are opened and closedselectively by a switching transistor such as insulated gate bipolartransistors (IGBTs), silicon carbide field effect transistors (SiCFETs), metal-oxide semiconductor field effect transistors (MOSFETS),silicon-controlled rectifiers (SCRs), or other high current switchingdevices. Switching a pair of transistors to a closed position, forexample switches 1229 a and 1229 c, enables current to flow in a firstdirection for first pulse segment P1. Opening switches 1229 a and 1229 cand closing switches 1229 b and 1229 d enables current to flow throughthe torso 5 of the patient 101 in a second pulse segment P2directionally opposite the flow of the first pulse segment P1.

Although the subject matter contained herein has been described indetail for the purpose of illustration, it is to be understood that suchdetail is solely for that purpose and that the present disclosure is notlimited to the disclosed embodiments, but, on the contrary, is intendedto cover modifications and equivalent arrangements that are within thespirit and scope of the appended claims. For example, it is to beunderstood that the present disclosure contemplates that, to the extentpossible, one or more features of any embodiment can be combined withone or more features of any other embodiment.

Other examples are within the scope and spirit of the description andclaims. Additionally, certain functions described above can beimplemented using software, hardware, firmware, hardwiring, orcombinations of any of these. Features implementing functions can alsobe physically located at various positions, including being distributedsuch that portions of functions are implemented at different physicallocations.

What is claimed is:
 1. A device controller for a wearable cardiactreatment device for continuous extended use by an ambulatory patient,the device controller comprising: a housing defining an interior volume;a frame positioned within the interior volume of the housing, the framecomprising at least one pocket; at least one capacitor configured to bereceived within the at least one pocket; an insulating compound disposedwithin the pocket to at least partially encapsulate the at least onecapacitor thereby immovably binding the at least one capacitor to theframe; a first circuit board positioned within the interior volume ofthe housing and affixed to a first side of the frame; and a secondcircuit board positioned within the interior volume of the housing andaffixed to an opposing second side of the frame in a manner to allow forseparation of the first and second circuit boards from the frame duringservice, wherein the first and second circuit boards comprise cardiacarrhythmia monitoring circuitry for analyzing an ECG signal receivedfrom the patient for an arrhythmia condition and comprising therapycircuitry in electrical communication with the at least one capacitorconfigured to cause delivery of energy from the at least one capacitorto a thoracic region of the patient.
 2. The device controller of claim1, wherein the at least one capacitor and the frame form a unitary mass.3. The device controller of claim 1, wherein the insulating compoundcomprises an epoxy resin that when set after initial application has ahardness rating in a range of about 80-85 Shore D.
 4. The devicecontroller of claim 1, wherein the insulating compound is an adhesivecompound.
 5. The device controller of claim 1, wherein the insulatingcompound has a tensile strength in a range of about 8,000-12,000 PSI, acompressive strength in a range of about 20,000-24,000 PSI, and aflexural strength in a range of about 14,000-20,000 PSI.
 6. The devicecontroller of claim 1, wherein the insulating compound has a dielectricstrength less than or equal to 6.0 at both 1 kHz and 1 MHz.
 7. Thedevice controller of claim 1, wherein the insulating compound has adissipation factor of less than or equal to 0.03 at 1 kHz and less thanor equal to 0.05 at 1 MHz.
 8. The device controller of claim 1, whereinthe at least one capacitor comprises a single capacitor.
 9. The devicecontroller of claim 8, wherein the single capacitor is configured tooccupy at least 50 to 95 percent of a volume defined within the pocketof the frame.
 10. The device controller of claim 1, wherein the firstcircuit board comprises at least one processor and high voltagecircuitry in communication with the at least one processor.
 11. Thedevice controller of claim 10, wherein the at least one processorcomprises an arrhythmia detection processor.
 12. The device controllerof claim 10, wherein the at least one processor comprises an arrhythmiadetection processor and a therapy control processor.
 13. The devicecontroller of claim 10, wherein the high voltage circuitry comprises atherapy delivery circuit.
 14. The device controller of claim 1, furthercomprising a flex connector extending from the first circuit board tothe second circuit board.
 15. The device controller of claim 1, whereinthe second circuit board comprises low voltage circuitry.
 16. The devicecontroller of claim 15, wherein the low voltage circuitry comprisescommunication circuitry.
 17. The device controller of claim 1, whereinthe frame, the at least one capacitor, and the first and second circuitboards occupy between about 25 to 90 percent of the interior volume ofthe housing.
 18. The device controller of claim 1, wherein the housingcomprises a rear shell configured to be disposed adjacent the secondcircuit board and a front shell configured to be disposed adjacent thefirst circuit board, the front shell mating with the rear shell in asealed configuration.
 19. The device controller of claim 18, wherein amating edge of the front shell and a mating edge of the rear shell areconfigured to engage in a fitted interlock when the front and rearshells are mated to form the housing.
 20. The device controller of claim1, wherein the housing comprises an IP67 rating as set forth in IEC60529 Standard for Ingress Protection.